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Model 16-22551012-SP · ACUITY SURGICAL DEVICES, LLC · DI 00810043486576

OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar · Class II · 21 CFR 888.3080

UDILibrary device dossier · generated 2026-09-07 · 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.

13452019-01: 0 reports for this device; peer average 1.33/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1.14/device2019-05: 0 reports for this device; peer average 1.33/device2019-06: 0 reports for this device; peer average 1.86/device2019-07: 0 reports for this device; peer average 1.44/device2019-08: 0 reports for this device; peer average 1.25/device2019-09: 0 reports for this device; peer average 3/device2019-10: 0 reports for this device; peer average 4/device2019-11: 0 reports for this device; peer average 1.4/device2019-12: 0 reports for this device; peer average 1.83/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2.4/device2020-03: 0 reports for this device; peer average 1.69/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1.4/device2020-06: 0 reports for this device; peer average 4.5/device2020-07: 0 reports for this device; peer average 4.8/device2020-08: 0 reports for this device; peer average 1.33/device2020-09: 0 reports for this device; peer average 5/device2020-10: 0 reports for this device; peer average 2.63/device2020-11: 0 reports for this device; peer average 3.38/device2020-12: 0 reports for this device; peer average 1.29/device2021-01: 0 reports for this device; peer average 2.67/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.82/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2.71/device2021-06: 0 reports for this device; peer average 2.78/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 2.86/device2021-09: 0 reports for this device; peer average 1.7/device2021-10: 0 reports for this device; peer average 2.71/device2021-11: 0 reports for this device; peer average 2.33/device2021-12: 0 reports for this device; peer average 3.13/device2022-01: 0 reports for this device; peer average 3.67/device2022-02: 0 reports for this device; peer average 3.71/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1.75/device2022-05: 0 reports for this device; peer average 2.63/device2022-06: 0 reports for this device; peer average 1.56/device2022-07: 0 reports for this device; peer average 1.89/device2022-08: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 2.29/device2022-10: 0 reports for this device; peer average 1.75/device2022-11: 0 reports for this device; peer average 1.57/device2022-12: 0 reports for this device; peer average 1.62/device2023-01: 0 reports for this device; peer average 1.75/device2023-02: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 1.78/device2023-04: 0 reports for this device; peer average 2.11/device2023-05: 0 reports for this device; peer average 1.43/device2023-06: 0 reports for this device; peer average 1.33/device2023-07: 0 reports for this device; peer average 1.8/device2023-08: 0 reports for this device; peer average 1.62/device2023-09: 0 reports for this device; peer average 1.67/device2023-10: 0 reports for this device; peer average 1.29/device2023-11: 0 reports for this device; peer average 2.33/device2023-12: 0 reports for this device; peer average 1.33/device2024-01: 0 reports for this device; peer average 1.91/device2024-02: 0 reports for this device; peer average 1.83/device2024-03: 0 reports for this device; peer average 1.64/device2024-04: 0 reports for this device; peer average 2.33/device2024-05: 0 reports for this device; peer average 2.33/device2024-06: 0 reports for this device; peer average 1.86/device2024-07: 0 reports for this device; peer average 2.14/device2024-08: 0 reports for this device; peer average 1.83/device2024-09: 0 reports for this device; peer average 1.79/device2024-10: 0 reports for this device; peer average 1.86/device2024-11: 0 reports for this device; peer average 1.83/device2024-12: 0 reports for this device; peer average 2.57/device2025-01: 0 reports for this device; peer average 1.4/device2025-02: 0 reports for this device; peer average 1.5/device2025-03: 0 reports for this device; peer average 1.55/device2025-04: 0 reports for this device; peer average 1.57/device2025-05: 0 reports for this device; peer average 1.6/device2025-06: 0 reports for this device; peer average 1.67/device2025-07: 0 reports for this device; peer average 2.8/device2025-08: 0 reports for this device; peer average 1.57/device2025-09: 0 reports for this device; peer average 2.11/device2025-10: 0 reports for this device; peer average 1.75/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1.73/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.36/device2026-03: 0 reports for this device; peer average 2.25/device2026-04: 0 reports for this device; peer average 1.7/device2026-05: 0 reports for this device; peer average 1.56/device2026-06: 0 reports for this device; peer average 1.73/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.33
2019-0202
2019-0302
2019-0401.14
2019-0501.33
2019-0601.86
2019-0701.44
2019-0801.25
2019-0903
2019-1004
2019-1101.4
2019-1201.83
2020-0102
2020-0202.4
2020-0301.69
2020-0401
2020-0501.4
2020-0604.5
2020-0704.8
2020-0801.33
2020-0905
2020-1002.63
2020-1103.38
2020-1201.29
2021-0102.67
2021-0202
2021-0301.82
2021-0402
2021-0502.71
2021-0602.78
2021-0703
2021-0802.86
2021-0901.7
2021-1002.71
2021-1102.33
2021-1203.13
2022-0103.67
2022-0203.71
2022-0302
2022-0401.75
2022-0502.63
2022-0601.56
2022-0701.89
2022-0803
2022-0902.29
2022-1001.75
2022-1101.57
2022-1201.62
2023-0101.75
2023-0201.5
2023-0301.78
2023-0402.11
2023-0501.43
2023-0601.33
2023-0701.8
2023-0801.62
2023-0901.67
2023-1001.29
2023-1102.33
2023-1201.33
2024-0101.91
2024-0201.83
2024-0301.64
2024-0402.33
2024-0502.33
2024-0601.86
2024-0702.14
2024-0801.83
2024-0901.79
2024-1001.86
2024-1101.83
2024-1202.57
2025-0101.4
2025-0201.5
2025-0301.55
2025-0401.57
2025-0501.6
2025-0601.67
2025-0702.8
2025-0801.57
2025-0902.11
2025-1001.75
2025-1101
2025-1201.73
2026-0101
2026-0201.36
2026-0302.25
2026-0401.7
2026-0501.56
2026-0601.73
This device (reports/month)Average device in OVD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K221535 — cites (transitively): K133967 (d1), K201614 (d1), K201671 (d1), K130573 (d2), K101225 (d2), K170392 (d2), K182139 (d2), K183064 (d2), K190025 (d2), K083475 (d2), K133827 (d2), K162212 (d2), K172816 (d2), K191391 (d2), K925765 (d3), K944964 (d3), K961728 (d3), K072791 (d3), K081917 (d3), K071922 (d3), K073109 (d3), K080314 (d3), K091301 (d3), K102090 (d3), K110327 (d3), K111626 (d3), K120345 (d3), K123767 (d3), K133577 (d3), K150135 (d3), K151128 (d3), K051859 (d3), K072570 (d3), K081653 (d3), K092035 (d3), K120414 (d3), K120991 (d3), K142277 (d3), K162103 (d3), K162236 (d3), K162496 (d3), K163269 (d3), K180078 (d3), K021932 (d3), K150321 (d3), K171595 (d3), K102293 (d3), K160597 (d3), K163361 (d3), K170157 (d3), K170318 (d3), K181357 (d3), K072970 (d4), K093242 (d4), K082262 (d4), K090507 (d4), K080615 (d4), K042571 (d4), K050624 (d4), K061836 (d4), K062132 (d4), K082014 (d4), P960025 (d4), K063286 (d4), K072624 (d4), K080396 (d4), K081666 (d4), K083496 (d4), K083805 (d4), K091239 (d4), K101005 (d4), K101849 (d4), K120338 (d4), K974738 (d4), K980698 (d4), K083026 (d4), K100175 (d4), K112405 (d4), K113528 (d4), K122591 (d4), K123027 (d4), K132897 (d4), K071724 (d4), K081888 (d4), K120368 (d4), K140474 (d4), K071416 (d4), K100043 (d4), K122037 (d4), K123045 (d4), K131669 (d4), K133650 (d4), K142450 (d4), K991460 (d4), P970015 (d4), K073291 (d4), K102957 (d4), K130177 (d4), K082252 (d4), K120101 (d4), K150643 (d4), K073669 (d4), K120570 (d4), K140142 (d4), K153107 (d4), K153495 (d4), K141953 (d4), K000682 (d4), K000684 (d4), K011815 (d4), K040112 (d4), K041860 (d4), K041965 (d4), K060290 (d4), K060514 (d4), K063049 (d4), K070946 (d4), K073460 (d4), K082625 (d4), K083032 (d4), K083286 (d4), K092556 (d4), K102694 (d4), K111620 (d4), K112437 (d4), K133668 (d4), K133974 (d4), K140814 (d4), K142906 (d4), K143697 (d4), K153716 (d4), K951303 (d4), K982732 (d4), K142218 (d4), K142397 (d4), K142498 (d4), K143578 (d4), P950002 (d4), K120275 (d4), K153615 (d4), K160125 (d4), K000080 (d4), K024060 (d4), K082792 (d4), K091967 (d4), K112028 (d4), K130092 (d4), K962011 (d4), K100865 (d4), K102313 (d4), K122097 (d4), K123231 (d4), K130478 (d4), K131276 (d4), K151665 (d4), K152022 (d4), K161223 (d4), K170962 (d4), K171031 (d4), K014072 (d5), K050966 (d5), K072857 (d5), K073337 (d5), K082468 (d5), K982447 (d5), K073470 (d5), K080758 (d5), K083661 (d5), K093704 (d5), K070833 (d5), K012694 (d5), K083694 (d5), K102257 (d5), K963798 (d5), K043248 (d5), K052776 (d5), K090353 (d5), K073285 (d5), K100214 (d5), P980048 (d5), K033926 (d5), K071795 (d5), K094025 (d5), K103731 (d5), K050553 (d5), K072465 (d5), K091426 (d5), K030327 (d5), K091813 (d5), K094042 (d5), K113447 (d5), K082732 (d5), K080537 (d5), K031302 (d5), K040284 (d5), K072991 (d5), K083389 (d5), K072253 (d5), K103382 (d5), K690353 (d5), K121760 (d5), K052483 (d5), K121672 (d5), K963172 (d5), K040022 (d5), K080667 (d5), K132502 (d5), K062151 (d5), K130699 (d5), K101720 (d5), K090675 (d5), K132886 (d5), K032812 (d5), K083714 (d5), K100889 (d5), K102067 (d5), K140055 (d5), K011084 (d5), K140482 (d5), K140417 (d5), K051567 (d5), K103332 (d5), K060665 (d5), K112756 (d5), K121107 (d5), K131449 (d5), K101421 (d5), K955472 (d5), K101301 (d5), K141942 (d5), K143163 (d5), K100210 (d5), K123997 (d5), K143740 (d5), K113285 (d5), K142645 (d5), K152475 (d5), K142026 (d5), K142345 (d5), K001945 (d5), K011978 (d5), K012114 (d5), K023802 (d5), K030597 (d5), K030858 (d5), K033975 (d5), K033995 (d5), K040777 (d5), K051986 (d5), K061753 (d5), K062494 (d5), K062564 (d5), K082807 (d5), K092493 (d5), K092812 (d5), K983787 (d5), K082698 (d5), K103169 (d5), K133494 (d5), K133614 (d5), K150362 (d5), K150481 (d5), K152304 (d5), K140479 (d5), K141665 (d5), K120918 (d5), K153419 (d5), K161230 (d5), K110543 (d5), K132053 (d5), K013248 (d6), K020602 (d6), K072832 (d6), K080522 (d6), K052261 (d6), P950019 (d6), K073177 (d6), K090425 (d6), K091088 (d6), K092336 (d6), P000028 (d6), K082801 (d6), K072083 (d6), K082300 (d6), K101302 (d6), K033805 (d6), K092038 (d6), K003275 (d6), K041389 (d6), K050850 (d6), K060506 (d6), K090841 (d6), K042695 (d6), K031672 (d6), K110843 (d6), K000636 (d6), K063875 (d6), K073527 (d6), K100271 (d6), K101056 (d6), K113760 (d6), K060736 (d6), K061748 (d6), K062216 (d6), K101240 (d6), K993106 (d6), K092211 (d6), K120031 (d6), K122630 (d6), K100967 (d6), K132584 (d6), K080508 (d6), K080699 (d6), K090816 (d6), K113348 (d6), K130820 (d6), K131082 (d6), K132601 (d6), K133455 (d6), K140319 (d6), K101310 (d6), K111122 (d6), K133200 (d6), K133286 (d6), K090064 (d6), K110733 (d6), K113518 (d6), K093864 (d6), K101051 (d6), K120869 (d6), K133328 (d6), K141217 (d6), K110632 (d6), K081611 (d6), K140003 (d6), K140921 (d6), K142050 (d6), K142264 (d6), K100945 (d6), K112316 (d6), K113138 (d6), K113561 (d6), K141405 (d6), K123486 (d6), K132624 (d6), K143393 (d6), K143616 (d6), K103111 (d6), K121649 (d6), K150994 (d6), K151472 (d6), K141896 (d6), K153782 (d6), K160051 (d6), K090166 (d7), K040593 (d7), K080401 (d7), K073202 (d7), K083626 (d7), K073348 (d7), K073351 (d7), K082260 (d7), K051454 (d7), K063399 (d7), K080024 (d7), K083186 (d7), K083894 (d7), K031635 (d7), K080568 (d7), K101923 (d7), K062083 (d7), K101812 (d7), K080971 (d7), K092070 (d7), K072160 (d7), K023570 (d7), K062933 (d7), K082310 (d7), K091278 (d7), K092193 (d7), K100042 (d7), K132594 (d7), K130548 (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), K072415 (d7), K043206 (d7), K133623 (d7), K123206 (d7), K122967 (d7), K081968 (d7), K100089 (d7), K131372 (d7), K140659 (d7), K053340 (d7), K100391 (d7), K131723 (d7), K003836 (d8), K010930 (d8), K043479 (d8), K042871 (d8), K052888 (d8), K092904 (d8), K050539 (d8), K063423 (d8), K974556 (d8), K092901 (d8), K083447 (d8) — cited as predicate by K241413, K251335

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

Manufacturer compliance record — ACUITY SURGICAL DEVICES, LLC

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