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IB3D™ PL Spinal System

Model B241C17062209 · MEDICREA INTERNATIONAL · DI 03613720286295

MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080

UDILibrary device dossier · generated 2026-09-06 · 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.

358102019-01: 0 reports for this device; peer average 1.54/device2019-02: 0 reports for this device; peer average 1.22/device2019-03: 0 reports for this device; peer average 1.69/device2019-04: 0 reports for this device; peer average 1.46/device2019-05: 0 reports for this device; peer average 1.6/device2019-06: 0 reports for this device; peer average 1.57/device2019-07: 0 reports for this device; peer average 1.65/device2019-08: 0 reports for this device; peer average 1.36/device2019-09: 0 reports for this device; peer average 1.32/device2019-10: 0 reports for this device; peer average 1.83/device2019-11: 0 reports for this device; peer average 1.58/device2019-12: 0 reports for this device; peer average 1.36/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.73/device2020-03: 0 reports for this device; peer average 1.45/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1.64/device2020-06: 0 reports for this device; peer average 1.84/device2020-07: 0 reports for this device; peer average 1.85/device2020-08: 0 reports for this device; peer average 1.63/device2020-09: 0 reports for this device; peer average 2.52/device2020-10: 0 reports for this device; peer average 2.05/device2020-11: 0 reports for this device; peer average 2.1/device2020-12: 0 reports for this device; peer average 1.76/device2021-01: 0 reports for this device; peer average 1.7/device2021-02: 0 reports for this device; peer average 1.72/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1.55/device2021-05: 0 reports for this device; peer average 1.6/device2021-06: 0 reports for this device; peer average 2.23/device2021-07: 0 reports for this device; peer average 1.73/device2021-08: 0 reports for this device; peer average 2.21/device2021-09: 0 reports for this device; peer average 1.72/device2021-10: 0 reports for this device; peer average 2.11/device2021-11: 0 reports for this device; peer average 1.84/device2021-12: 0 reports for this device; peer average 2.54/device2022-01: 0 reports for this device; peer average 3.14/device2022-02: 0 reports for this device; peer average 2.62/device2022-03: 0 reports for this device; peer average 1.78/device2022-04: 0 reports for this device; peer average 1.76/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 1.79/device2022-07: 0 reports for this device; peer average 2.21/device2022-08: 0 reports for this device; peer average 1.86/device2022-09: 0 reports for this device; peer average 1.78/device2022-10: 0 reports for this device; peer average 1.87/device2022-11: 0 reports for this device; peer average 1.93/device2022-12: 0 reports for this device; peer average 1.7/device2023-01: 0 reports for this device; peer average 2.44/device2023-02: 0 reports for this device; peer average 2.05/device2023-03: 0 reports for this device; peer average 1.71/device2023-04: 0 reports for this device; peer average 1.81/device2023-05: 0 reports for this device; peer average 2.04/device2023-06: 0 reports for this device; peer average 1.75/device2023-07: 0 reports for this device; peer average 2.04/device2023-08: 0 reports for this device; peer average 1.73/device2023-09: 0 reports for this device; peer average 1.97/device2023-10: 0 reports for this device; peer average 1.85/device2023-11: 0 reports for this device; peer average 10.03/device2023-12: 0 reports for this device; peer average 3.95/device2024-01: 0 reports for this device; peer average 1.86/device2024-02: 0 reports for this device; peer average 2.13/device2024-03: 0 reports for this device; peer average 1.9/device2024-04: 0 reports for this device; peer average 1.36/device2024-05: 0 reports for this device; peer average 1.58/device2024-06: 0 reports for this device; peer average 1.79/device2024-07: 0 reports for this device; peer average 1.93/device2024-08: 0 reports for this device; peer average 2.27/device2024-09: 0 reports for this device; peer average 1.9/device2024-10: 0 reports for this device; peer average 2.13/device2024-11: 0 reports for this device; peer average 1.74/device2024-12: 0 reports for this device; peer average 1.69/device2025-01: 0 reports for this device; peer average 1.85/device2025-02: 0 reports for this device; peer average 1.66/device2025-03: 0 reports for this device; peer average 1.66/device2025-04: 0 reports for this device; peer average 1.6/device2025-05: 0 reports for this device; peer average 1.65/device2025-06: 0 reports for this device; peer average 2.02/device2025-07: 0 reports for this device; peer average 1.81/device2025-08: 0 reports for this device; peer average 1.61/device2025-09: 0 reports for this device; peer average 1.59/device2025-10: 0 reports for this device; peer average 1.71/device2025-11: 0 reports for this device; peer average 2.03/device2025-12: 0 reports for this device; peer average 1.85/device2026-01: 0 reports for this device; peer average 1.94/device2026-02: 0 reports for this device; peer average 1.53/device2026-03: 0 reports for this device; peer average 2.76/device2026-04: 0 reports for this device; peer average 1.57/device2026-05: 0 reports for this device; peer average 1.58/device2026-06: 0 reports for this device; peer average 1.6/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.54
2019-0201.22
2019-0301.69
2019-0401.46
2019-0501.6
2019-0601.57
2019-0701.65
2019-0801.36
2019-0901.32
2019-1001.83
2019-1101.58
2019-1201.36
2020-0101.67
2020-0201.73
2020-0301.45
2020-0401.43
2020-0501.64
2020-0601.84
2020-0701.85
2020-0801.63
2020-0902.52
2020-1002.05
2020-1102.1
2020-1201.76
2021-0101.7
2021-0201.72
2021-0302
2021-0401.55
2021-0501.6
2021-0602.23
2021-0701.73
2021-0802.21
2021-0901.72
2021-1002.11
2021-1101.84
2021-1202.54
2022-0103.14
2022-0202.62
2022-0301.78
2022-0401.76
2022-0502.13
2022-0601.79
2022-0702.21
2022-0801.86
2022-0901.78
2022-1001.87
2022-1101.93
2022-1201.7
2023-0102.44
2023-0202.05
2023-0301.71
2023-0401.81
2023-0502.04
2023-0601.75
2023-0702.04
2023-0801.73
2023-0901.97
2023-1001.85
2023-11010.03
2023-1203.95
2024-0101.86
2024-0202.13
2024-0301.9
2024-0401.36
2024-0501.58
2024-0601.79
2024-0701.93
2024-0802.27
2024-0901.9
2024-1002.13
2024-1101.74
2024-1201.69
2025-0101.85
2025-0201.66
2025-0301.66
2025-0401.6
2025-0501.65
2025-0602.02
2025-0701.81
2025-0801.61
2025-0901.59
2025-1001.71
2025-1102.03
2025-1201.85
2026-0101.94
2026-0201.53
2026-0302.76
2026-0401.57
2026-0501.58
2026-0601.6
This device (reports/month)Average device in MAX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K241164 — cites (transitively): K163595 (d1), K192502 (d1), K201267 (d1), K072226 (d2), K083798 (d2), K121760 (d2), K150481 (d2), K151214 (d2), K073291 (d2), K083026 (d2), K090353 (d2), K091813 (d2), K094025 (d2), K100175 (d2), K100214 (d2), K103731 (d2), K110543 (d2), K111264 (d2), K112405 (d2), K112444 (d2), K113528 (d2), K113642 (d2), K120368 (d2), K121982 (d2), K122037 (d2), K123978 (d2), K130177 (d2), K131669 (d2), K132700 (d2), K132897 (d2), K133205 (d2), K133216 (d2), K133645 (d2), K133650 (d2), K133653 (d2), K141599 (d2), K142450 (d2), K142559 (d2), K150135 (d2), K151128 (d2), K152277 (d2), K153373 (d2), K160418 (d2), K160528 (d2), K162212 (d2), K162680 (d2), K171031 (d2), K171107 (d2), K172199 (d2), K172328 (d2), K173125 (d2), K181328 (d2), K182885 (d2), K183510 (d2), K190165 (d2), K190959 (d2), K192018 (d2), K123027 (d2), K171689 (d2), K191581 (d2), K052261 (d3), P950019 (d3), P960025 (d3), K073285 (d3), K091088 (d3), K092336 (d3), P000028 (d3), P980048 (d3), K081917 (d3), K093093 (d3), K094042 (d3), K033926 (d3), K071795 (d3), K030327 (d3), K082732 (d3), K122591 (d3), K690353 (d3), K100967 (d3), K113252 (d3), K130640 (d3), K140417 (d3), K072970 (d3), K083626 (d3), K102293 (d3), K113447 (d3), K121333 (d3), K071416 (d3), K100043 (d3), K123045 (d3), K991460 (d3), P970015 (d3), K082698 (d3), K100945 (d3), K110843 (d3), K112316 (d3), K113138 (d3), K113561 (d3), K130699 (d3), K133614 (d3), K141405 (d3), K133577 (d3), K073109 (d3), K120918 (d3), K141942 (d3), K091442 (d3), K132584 (d3), K111525 (d3), K142264 (d3), K132053 (d3), K121332 (d3), K160547 (d3), K162358 (d3), K170592 (d3), K052931 (d3), K071033 (d3), K083186 (d3), K100976 (d3), K012254 (d3), K151651 (d3), K162315 (d3), K172032 (d3), K021461 (d3), K021761 (d3), K042922 (d3), K061274 (d3), K063100 (d3), K081038 (d3), K141632 (d3), K152623 (d3), K970806 (d3), K992110 (d3), K994239 (d3), K080615 (d3), K140055 (d3), K142589 (d3), K163269 (d3), K170399 (d3), K173535 (d3), K183557 (d3), K141953 (d3), K153122 (d3), K003836 (d4), K010930 (d4), K080401 (d4), K082112 (d4), K091883 (d4), K093242 (d4), K051454 (d4), K063399 (d4), K080024 (d4), K080699 (d4), K083894 (d4), K073202 (d4), K031672 (d4), K103169 (d4), K132594 (d4), K101302 (d4), K102067 (d4), K071724 (d4), K081968 (d4), K100089 (d4), K131372 (d4), K030866 (d4), K101301 (d4), K101310 (d4), K102090 (d4), K111122 (d4), K133200 (d4), K133286 (d4), K032812 (d4), K083714 (d4), K100889 (d4), K111626 (d4), K081611 (d4), K142205 (d4), K142940 (d4), K151596 (d4), K112756 (d4), K152568 (d4), K150673 (d4), K151276 (d4), K151773 (d4), K160051 (d4), K160125 (d4), K110864 (d4), K133802 (d4), K142150 (d4), K148529 (d4), K170676 (d4), K171686 (d4), K172676 (d4), K180364 (d4), P950002 (d5), K082801 (d5), K024049 (d5), K060416 (d5), K003275 (d5), K041389 (d5), K050850 (d5), K060506 (d5), K060665 (d5), K090064 (d5), K083447 (d5), K072415 (d5), K080568 (d5), K030349 (d5), K032476 (d5), K061891 (d5), K090176 (d5), K113559 (d5), K120819 (d5), K133494 (d5), K072253 (d5), K072981 (d5), K122639 (d5), K131276 (d5), K140759 (d5), K143163 (d5), K121176 (d5), K142030 (d5), K131723 (d5), K140479 (d5), K153419 (d5), K072991 (d5), K150362 (d5), K152304 (d5), K072791 (d5), K120570 (d5), K153107 (d5), K162103 (d5), K120603 (d5), K140003 (d5), K162138 (d5), K163230 (d5), K163491 (d5), K120275 (d5), K162264 (d5), K171496 (d5), K050553 (d6), K072465 (d6), K091426 (d6), K111123 (d6), K071833 (d6), K003043 (d6), K090507 (d6), K103382 (d6), K092211 (d6), K120031 (d6), K122630 (d6), K123206 (d6), K001340 (d6), K023835 (d6), K030833 (d6), K052746 (d6), K073649 (d6), K082128 (d6), K110454 (d6), K110694 (d6), K131724 (d6), K083661 (d6), K093704 (d6), K093864 (d6), K100865 (d6), K101051 (d6), K120869 (d6), K133328 (d6), K141217 (d6), K140921 (d6), K142050 (d6), K123486 (d6), K132624 (d6), K143393 (d6), K143616 (d6), K073669 (d6), K100210 (d6), K120991 (d6), K123997 (d6), K140142 (d6), K143740 (d6), K150994 (d6), K151472 (d6), K153495 (d6), K140319 (d6), K160916 (d6), K141665 (d6), K161230 (d6), K101171 (d6), K142251 (d6), K152532 (d6), K160924 (d6), K162262 (d6), K090166 (d7), K073177 (d7), K090425 (d7), K073470 (d7), K080758 (d7), K082014 (d7), K082252 (d7), K090899 (d7), K101923 (d7), K062083 (d7), K083475 (d7), K080971 (d7), K092070 (d7), K043479 (d7), K072160 (d7), K031729 (d7), K040267 (d7), K042883 (d7), K042993 (d7), K051146 (d7), K051380 (d7), K051977 (d7), K053514 (d7), K061521 (d7), K072221 (d7), K072575 (d7), K123166 (d7), K062151 (d7), K110632 (d7), K113348 (d7), K122967 (d7), K132601 (d7), K090816 (d7), K123231 (d7), K130820 (d7), K131082 (d7), K133455 (d7), K120486 (d7), K053340 (d7), K100391 (d7), K140659 (d7), K141896 (d7), K102606 (d7), K142066 (d7), K150053 (d7), K082262 (d7), K110327 (d7), K113285 (d7), K142645 (d7), K150643 (d7), K152475 (d7), K153782 (d7), K150788 (d7), K151310 (d7), K151322 (d7), K151726 (d7), K160955 (d7), K042871 (d8), K052888 (d8), K073348 (d8), K031635 (d8), K050539 (d8), K063423 (d8), K974556 (d8), K080537 (d8), K023570 (d8), K062933 (d8), K082310 (d8), K091278 (d8), K092193 (d8), K100042 (d8), K130548 (d8), K043206 (d8), K133623 (d8), K080281 (d8), K081614 (d8), K122989 (d8), K103111 (d8), K121649 (d8) — cited as predicate by K253577

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

Manufacturer compliance record — MEDICREA INTERNATIONAL

  • VAI 2017-02-16 Medicrea International · 5 citations
  • VAI 2013-06-20 Medicrea International · 0 citations
  • VAI 2013-06-19 Medicrea International · 5 citations