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Ascend

Model 153-12-B-185010-S · ALPHATEC SPINE, INC. · DI 00190376521176

PLR — Spinal Vertebral Body Replacement Device - Cervical · Class II · 21 CFR 888.3060

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

24572019-10: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 2.5/device2020-04: 0 reports for this device; peer average 1.5/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 3.33/device2020-08: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1.5/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 7/device2021-07: 0 reports for this device; peer average 2.33/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1.33/device2022-02: 0 reports for this device; peer average 1.25/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1.2/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1.8/device2022-12: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 5.33/device2023-05: 0 reports for this device; peer average 1.5/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 4/device2023-08: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1.5/device2024-04: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 4/device2025-05: 0 reports for this device; peer average 3/device2025-06: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 3/device2025-09: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device101201020304050607080910111201020304050607091112010203040506071012030506070812020406070911120102030405060809111201020304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1001
2019-1201
2020-0102
2020-0201
2020-0302.5
2020-0401.5
2020-0501
2020-0601
2020-0703.33
2020-0803
2020-0901
2020-1002
2020-1102
2020-1202
2021-0101
2021-0201
2021-0302
2021-0401.5
2021-0501
2021-0607
2021-0702.33
2021-0901
2021-1101.5
2021-1201
2022-0101.33
2022-0201.25
2022-0301.5
2022-0401
2022-0501.2
2022-0601
2022-0701
2022-1001.8
2022-1201
2023-0305.33
2023-0501.5
2023-0601
2023-0704
2023-0802
2023-1201
2024-0201.5
2024-0401
2024-0601
2024-0701
2024-0901
2024-1101
2024-1201
2025-0101
2025-0201
2025-0303
2025-0404
2025-0503
2025-0602
2025-0803
2025-0901.5
2025-1101
2025-1201
2026-0101
2026-0201.5
2026-0301
2026-0401
This device (reports/month)Average device in PLR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K232173 — cites (transitively): K050553 (d1), K161363 (d1), K180480 (d1), K192117 (d1), K192938 (d1), K193506 (d1), K211805 (d1), K222028 (d1), K222973 (d1), K100685 (d2), K133221 (d2), K142591 (d2), K143149 (d2), K152968 (d2), K080699 (d2), K151256 (d2), K160958 (d2), K161485 (d2), K171633 (d2), K012254 (d2), K173982 (d2), K841189 (d2), K180210 (d2), K181677 (d2), K191311 (d2), K142205 (d2), K151651 (d2), K192760 (d2), K181435 (d2), K183705 (d2), K201614 (d2), K202587 (d2), K203201 (d2), K182746 (d2), K210497 (d2), K214010 (d2), K220782 (d2), K172676 (d2), K192582 (d2), K211258 (d2), K033090 (d3), K071890 (d3), K003836 (d3), K030349 (d3), K032476 (d3), K061891 (d3), K090176 (d3), K031655 (d3), K042025 (d3), K052187 (d3), K141494 (d3), K140531 (d3), K141635 (d3), K081611 (d3), K013440 (d3), K142798 (d3), K143740 (d3), K150994 (d3), K110442 (d3), K133614 (d3), K140280 (d3), K071795 (d3), K140770 (d3), K141665 (d3), K153627 (d3), K161230 (d3), K170962 (d3), K120603 (d3), K140003 (d3), K162138 (d3), K163230 (d3), K163491 (d3), K081730 (d3), K141376 (d3), K150362 (d3), K171140 (d3), P980048 (d3), K131802 (d3), K160775 (d3), K090782 (d3), K101255 (d3), K102402 (d3), K121791 (d3), K163543 (d3), K173892 (d3), K181453 (d3), K182747 (d3), K131025 (d3), K142299 (d3), K150053 (d3), K140479 (d3), K172123 (d3), K101225 (d3), K170392 (d3), K182139 (d3), K183064 (d3), K190025 (d3), K160646 (d3), K153419 (d3), K170592 (d3), K172341 (d3), K173153 (d3), K181386 (d3), K181860 (d3), K193541 (d3), K193593 (d3), K200953 (d3), K201820 (d3), K142488 (d3), K171046 (d3), K173260 (d3), K173606 (d3), K181079 (d3), K183083 (d3), K190655 (d3), K192132 (d3), K193636 (d3), K200879 (d3), K201193 (d3), K192018 (d3), K201605 (d3), K073291 (d3), K094025 (d3), K123027 (d3), K171689 (d3), K212524 (d3), K202812 (d3), K202889 (d3), K203742 (d3), K052261 (d4), P950019 (d4), P960025 (d4), K925765 (d4), K944964 (d4), K961728 (d4), K043548 (d4), K072791 (d4), K073202 (d4), K080401 (d4), K080537 (d4), K100214 (d4), K111123 (d4), K022791 (d4), K052546 (d4), K061353 (d4), K091044 (d4), K082732 (d4), K000536 (d4), K053581 (d4), K111136 (d4), K082698 (d4), K101302 (d4), K103169 (d4), K123206 (d4), K081614 (d4), K103382 (d4), K123045 (d4), K093950 (d4), K091974 (d4), K140276 (d4), K081127 (d4), K121771 (d4), K090816 (d4), K113348 (d4), K120918 (d4), K123231 (d4), K130820 (d4), K131082 (d4), K132601 (d4), K133455 (d4), K140319 (d4), K092521 (d4), K102547 (d4), K132894 (d4), K140921 (d4), K082309 (d4), K082310 (d4), K082712 (d4), K102026 (d4), K103297 (d4), K112986 (d4), K123138 (d4), K110632 (d4), K142050 (d4), K142264 (d4), K140659 (d4), K151472 (d4), K143595 (d4), K082466 (d4), K082644 (d4), K123913 (d4), K061202 (d4), K132049 (d4), K141896 (d4), K153782 (d4), K160051 (d4), K160916 (d4), K150481 (d4), K152304 (d4), K141791 (d4), K051859 (d4), K072570 (d4), K081653 (d4), K092035 (d4), K120414 (d4), K151322 (d4), K162715 (d4), K120345 (d4), K160125 (d4), K121332 (d4), K121333 (d4), K122037 (d4), K133205 (d4), K151128 (d4), K160547 (d4), K162358 (d4), K143065 (d4), K153105 (d4), K163506 (d4), K162351 (d4), K073109 (d4), K080822 (d4), K101301 (d4), K101310 (d4), K121211 (d4), K100043 (d4), K140348 (d4), K162236 (d4), K162496 (d4), K163269 (d4), K091845 (d4), K102673 (d4), K180078 (d4), K032064 (d4), K050058 (d4), K101363 (d4), K111675 (d4), K161081 (d4), K170569 (d4), K172926 (d4), K173722 (d4), K021932 (d4), K150321 (d4), K171595 (d4), K141953 (d4), K153122 (d4), K170399 (d4), K173535 (d4), K183557 (d4), K190959 (d4), K152943 (d4), K200885 (d4), K201267 (d4), K201646 (d4), K172888 (d4), K181644 (d4), K183447 (d4), K170953 (d4), K200543 (d4), K110574 (d4), K121302 (d4), K133785 (d4), K151019 (d4), K151983 (d4), K163007 (d4), K170767 (d4), K193468 (d4), K083475 (d4), K102334 (d4), K091813 (d4), K123047 (d4), K132897 (d4), K133577 (d4), K152277 (d4), K201189 (d4), K210425 (d4), K020752 (d5), K020758 (d5), K040449 (d5), K092983 (d5), K073285 (d5), K091088 (d5), K092336 (d5), P000028 (d5), K080588 (d5), K073514 (d5), K092124 (d5), K983084 (d5), K081917 (d5), K082252 (d5), K093242 (d5), K033740 (d5), K063506 (d5), K071724 (d5), K073348 (d5), K031635 (d5), K080568 (d5), K101923 (d5), K042571 (d5), K050624 (d5), K061836 (d5), K062132 (d5), K082014 (d5), K063286 (d5), K072624 (d5), K080396 (d5), K081666 (d5), K083496 (d5), K083805 (d5), K091239 (d5), K101005 (d5), K101849 (d5), K120338 (d5), K974738 (d5), K980698 (d5), K101433 (d5), K120370 (d5), K030327 (d5), K083026 (d5), K094042 (d5), K053008 (d5), K954451 (d5), K043479 (d5), K072970 (d5), K023570 (d5), K062933 (d5), K091278 (d5), K092193 (d5), K100042 (d5), K031585 (d5), K102204 (d5), K111502 (d5), K983583 (d5), K130548 (d5), K073351 (d5), K103033 (d5), K111119 (d5), K112388 (d5), K090353 (d5), K100175 (d5), K043206 (d5), K133623 (d5), K112405 (d5), K113528 (d5), K122591 (d5), K091445 (d5), K111457 (d5), K132328 (d5), K132471 (d5), K122967 (d5), K123969 (d5), K132738 (d5), K133126 (d5), K133340 (d5), K123767 (d5), K131547 (d5), K032812 (d5), K080615 (d5), K083714 (d5), K100889 (d5), K102067 (d5), K111626 (d5), K140055 (d5), K130177 (d5), K021039 (d5), K040130 (d5), K072339 (d5), K072943 (d5), K090415 (d5), K121837 (d5), K102957 (d5), K120368 (d5), K100945 (d5), K110843 (d5), K112316 (d5), K113138 (d5), K113561 (d5), K130699 (d5), K141405 (d5), K133650 (d5), K032413 (d5), K070169 (d5), K072707 (d5), K110789 (d5), K122860 (d5), K151382 (d5), K931271 (d5), K071416 (d5), K091442 (d5), K131669 (d5), K150135 (d5), K991460 (d5), K060506 (d5), K123486 (d5), K132624 (d5), K143393 (d5), K143616 (d5), K151214 (d5), K151374 (d5), K142940 (d5), K151596 (d5), K131723 (d5), K143163 (d5), K072991 (d5), K133494 (d5), K151939 (d5), K161379 (d5), K100089 (d5), K150673 (d5), K151276 (d5), K151773 (d5), K143685 (d5), K946173 (d5), K000080 (d5), K024060 (d5), K082792 (d5), K091967 (d5), K112028 (d5), K130092 (d5), K962011 (d5), K170503 (d5), K102323 (d5), K142589 (d5), K148529 (d5), K121049 (d5), K130478 (d5), K143578 (d5), K150619 (d5), K153373 (d5), K161442 (d5), K161888 (d5), K181014 (d5), K170676 (d5), K171686 (d5), K180364 (d5), K161876 (d5), K190546 (d5), K072407 (d5), K171538 (d5), K170011 (d5), K142559 (d5), K191581 (d5), K131425 (d5), K133216 (d5), K150231 (d5), K163581 (d5), K171031 (d5), K014072 (d6), K050966 (d6), K072857 (d6), K073337 (d6), K082468 (d6), K982447 (d6), K073643 (d6), P950002 (d6), P970015 (d6), K082801 (d6), K070833 (d6), K040166 (d6), K082500 (d6), K933785 (d6), K943462 (d6), K961685 (d6), K024096 (d6), K102257 (d6), K070754 (d6), K093772 (d6), K051454 (d6), K063399 (d6), K080024 (d6), K083626 (d6), K083894 (d6), K083389 (d6), K033926 (d6), K103731 (d6), K103662 (d6), K040721 (d6), K051665 (d6), K070775 (d6), K092146 (d6), K051165 (d6), K072160 (d6), K090064 (d6), K031302 (d6), K040284 (d6), K102293 (d6), K092901 (d6), K031672 (d6), K124004 (d6), K690353 (d6), K050439 (d6), K090390 (d6), K101074 (d6), K981676 (d6), K031729 (d6), K040267 (d6), K042883 (d6), K042993 (d6), K051146 (d6), K051380 (d6), K051977 (d6), K053514 (d6), K061521 (d6), K072221 (d6), K072575 (d6), K123166 (d6), K073470 (d6), K090566 (d6), K121693 (d6), K073669 (d6), K090899 (d6), K100305 (d6), K101051 (d6), K111166 (d6), K092211 (d6), K120031 (d6), K122630 (d6), K121760 (d6), K081968 (d6), K131372 (d6), K113447 (d6), K072415 (d6), K113252 (d6), K113559 (d6), K120819 (d6), K083661 (d6), K093704 (d6), K093864 (d6), K100865 (d6), K120869 (d6), K133328 (d6), K141217 (d6), K053340 (d6), K100391 (d6), K060665 (d6), K072465 (d6), K102313 (d6), K112756 (d6), K120101 (d6), K121107 (d6), K122097 (d6), K131449 (d6), K133967 (d6), K133218 (d6), K142450 (d6), K140454 (d6), K142152 (d6), K072253 (d6), K072981 (d6), K121982 (d6), K122639 (d6), K131276 (d6), K141942 (d6), K140162 (d6), K143126 (d6), K140759 (d6), K100967 (d6), K111264 (d6), K132584 (d6), K150581 (d6), K141135 (d6), K050438 (d6), K153660 (d6), K093669 (d6), K112095 (d6), K122588 (d6), K143258 (d6), K110543 (d6), K132053 (d6), K120570 (d6), K153107 (d6), K162103 (d6), K120275 (d6), K162264 (d6), K171496 (d6), K160955 (d6), K052292 (d6), K132029 (d6), K181837 (d6), P110002 (d6), K082262 (d7), K090166 (d7), K052533 (d7), K080349 (d7), K042871 (d7), K052888 (d7), K080758 (d7), K040962 (d7), K050981 (d7), K101229 (d7), K093093 (d7), K003275 (d7), K041389 (d7), K050850 (d7), K062083 (d7), K091426 (d7), K071833 (d7), K090841 (d7), K080971 (d7), K092070 (d7), K090507 (d7), K050539 (d7), K063423 (d7), K974556 (d7), K132594 (d7), K112036 (d7), K122771 (d7), K130573 (d7), K001340 (d7), K023835 (d7), K030833 (d7), K052746 (d7), K073649 (d7), K082128 (d7), K110454 (d7), K110694 (d7), K081888 (d7), K103666 (d7), K133557 (d7), K102090 (d7), K111122 (d7), K133200 (d7), K133286 (d7), K101812 (d7), K121649 (d7), K132999 (d7), K133653 (d7), K140417 (d7), K142095 (d7), K103111 (d7), K935481 (d7), K100210 (d7), K120991 (d7), K123997 (d7), K140142 (d7), K150216 (d7), K992927 (d7), K153495 (d7), K101171 (d7), K142251 (d7), K152532 (d7), K160924 (d7), K162262 (d7), K150061 (d7), K152011 (d7), K170235 (d7), K073177 (d8), K090425 (d8), K091508 (d8), K093846 (d8), K092904 (d8), K052210 (d8), K083186 (d8), K083447 (d8), K102606 (d8), K062151 (d8), K140106 (d8), K120486 (d8), K142066 (d8), K110327 (d8), K113285 (d8), K142645 (d8), K150643 (d8), K152475 (d8), K150788 (d8), K151310 (d8), K151726 (d8), K162327 (d8)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — ALPHATEC SPINE, INC.

  • Warning Letter 2015-07-16 Alphatec Spine, Inc.
  • Warning Letter 2011-01-11 Alphatec Spine, Inc.
  • Warning Letter 2010-06-21 Alphatec Spine, Inc.
  • VAI 2017-04-19 Alphatec Spine, Inc. · 1 citations
  • VAI 2016-03-16 Alphatec Spine, Inc. · 1 citations
  • OAI 2015-03-13 Alphatec Spine, Inc. · 0 citations
  • NAI 2013-06-14 Alphatec Spine, Inc. · 0 citations
  • VAI 2012-04-27 Alphatec Spine, Inc. · 0 citations
  • VAI 2010-12-13 Alphatec Spine, Inc. · 7 citations
  • OAI 2010-02-11 Alphatec Spine, Inc. · 11 citations