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Model S1076-020 · Foundation Fusion Solutions, LLC · DI 00850026642254

FSM — Tray, Surgical, Instrument · Class I · 21 CFR 878.4800

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.

24682019-01: 0 reports for this device; peer average 1.6/device2019-02: 0 reports for this device; peer average 1.67/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.8/device2019-05: 0 reports for this device; peer average 1.4/device2019-06: 0 reports for this device; peer average 1.33/device2019-07: 0 reports for this device; peer average 1.4/device2019-08: 0 reports for this device; peer average 1.09/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2.77/device2019-11: 0 reports for this device; peer average 1.75/device2019-12: 0 reports for this device; peer average 1.92/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1.4/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 2.5/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 1.25/device2020-07: 0 reports for this device; peer average 2.78/device2020-08: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 3.13/device2020-10: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 4.17/device2020-12: 0 reports for this device; peer average 3.8/device2021-01: 0 reports for this device; peer average 4.4/device2021-02: 0 reports for this device; peer average 3/device2021-03: 0 reports for this device; peer average 3.46/device2021-04: 0 reports for this device; peer average 4/device2021-05: 0 reports for this device; peer average 2.33/device2021-06: 0 reports for this device; peer average 3.64/device2021-07: 0 reports for this device; peer average 1.88/device2021-08: 0 reports for this device; peer average 2.78/device2021-09: 0 reports for this device; peer average 3.75/device2021-10: 0 reports for this device; peer average 1.5/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 2.13/device2022-01: 0 reports for this device; peer average 1.67/device2022-02: 0 reports for this device; peer average 2.2/device2022-03: 0 reports for this device; peer average 2.29/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 7.4/device2022-06: 0 reports for this device; peer average 8/device2022-07: 0 reports for this device; peer average 2.6/device2022-08: 0 reports for this device; peer average 1.33/device2022-09: 0 reports for this device; peer average 5.17/device2022-10: 0 reports for this device; peer average 2.4/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1.57/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 1.75/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1.33/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.13/device2023-09: 0 reports for this device; peer average 1.08/device2023-10: 0 reports for this device; peer average 1.17/device2023-11: 0 reports for this device; peer average 1.64/device2023-12: 0 reports for this device; peer average 1.63/device2024-01: 0 reports for this device; peer average 1.25/device2024-02: 0 reports for this device; peer average 1.27/device2024-03: 0 reports for this device; peer average 3.85/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1.88/device2024-06: 0 reports for this device; peer average 3.07/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 1.9/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1.73/device2024-11: 0 reports for this device; peer average 3/device2024-12: 0 reports for this device; peer average 2.29/device2025-01: 0 reports for this device; peer average 3.33/device2025-02: 0 reports for this device; peer average 2.79/device2025-03: 0 reports for this device; peer average 2.57/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1.75/device2025-06: 0 reports for this device; peer average 1.14/device2025-07: 0 reports for this device; peer average 2.27/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 2.6/device2025-10: 0 reports for this device; peer average 1.33/device2025-11: 0 reports for this device; peer average 2.75/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1.64/device2026-02: 0 reports for this device; peer average 4.15/device2026-03: 0 reports for this device; peer average 2.29/device2026-04: 0 reports for this device; peer average 1.93/device2026-05: 0 reports for this device; peer average 2.71/device2026-06: 0 reports for this device; peer average 1.92/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.6
2019-0201.67
2019-0301
2019-0401.8
2019-0501.4
2019-0601.33
2019-0701.4
2019-0801.09
2019-0901
2019-1002.77
2019-1101.75
2019-1201.92
2020-0101
2020-0201.4
2020-0301
2020-0402.5
2020-0502
2020-0601.25
2020-0702.78
2020-0802
2020-0903.13
2020-1002
2020-1104.17
2020-1203.8
2021-0104.4
2021-0203
2021-0303.46
2021-0404
2021-0502.33
2021-0603.64
2021-0701.88
2021-0802.78
2021-0903.75
2021-1001.5
2021-1101.5
2021-1202.13
2022-0101.67
2022-0202.2
2022-0302.29
2022-0401
2022-0507.4
2022-0608
2022-0702.6
2022-0801.33
2022-0905.17
2022-1002.4
2022-1102
2022-1201.57
2023-0102.5
2023-0201.75
2023-0302
2023-0401.33
2023-0502
2023-0602
2023-0702
2023-0801.13
2023-0901.08
2023-1001.17
2023-1101.64
2023-1201.63
2024-0101.25
2024-0201.27
2024-0303.85
2024-0402
2024-0501.88
2024-0603.07
2024-0702
2024-0801.9
2024-0901
2024-1001.73
2024-1103
2024-1202.29
2025-0103.33
2025-0202.79
2025-0302.57
2025-0401
2025-0501.75
2025-0601.14
2025-0702.27
2025-0801.67
2025-0902.6
2025-1001.33
2025-1102.75
2025-1201
2026-0101.64
2026-0204.15
2026-0302.29
2026-0401.93
2026-0502.71
2026-0601.92
This device (reports/month)Average device in FSM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K211496 — cites (transitively): K021932 (d1), K180818 (d1), K192645 (d1), K200696 (d1), K110472 (d2), K131405 (d2), K161210 (d2), K140531 (d2), K151256 (d2), K161037 (d2), K170318 (d2), K182949 (d2), K121148 (d2), K183342 (d2), K051296 (d3), K080398 (d3), K092375 (d3), K102903 (d3), K110838 (d3), K914004 (d3), K123850 (d3), K093950 (d3), K141635 (d3), K113048 (d3), K120157 (d3), K141905 (d3), K142724 (d3), K150368 (d3), K111520 (d3), K124004 (d3), K140454 (d3), K150231 (d3), K120275 (d3), K153615 (d3), K160125 (d3), P960025 (d3), K014154 (d3), K081149 (d3), K973309 (d3), K991151 (d3), K991197 (d3), K151818 (d3), K162733 (d3), K172437 (d3), K182983 (d3), K061113 (d4), K061639 (d4), K063305 (d4), K081475 (d4), K061098 (d4), K061400 (d4), K090289 (d4), K092528 (d4), K093900 (d4), K100618 (d4), K102156 (d4), K101962 (d4), K111041 (d4), K073285 (d4), K100214 (d4), P980048 (d4), K122074 (d4), K050438 (d4), K081127 (d4), K121771 (d4), K070592 (d4), K073535 (d4), K131425 (d4), K141549 (d4), K142026 (d4), K142345 (d4), K150321 (d4), K072991 (d4), K082698 (d4), K103169 (d4), K133494 (d4), K133614 (d4), K150362 (d4), K150481 (d4), K152304 (d4), K150017 (d4), K160652 (d4), K121020 (d4), K051908 (d5), K061808 (d5), K080295 (d5), K091088 (d5), K092336 (d5), P000028 (d5), K073624 (d5), K081917 (d5), K101302 (d5), K102701 (d5), K111571 (d5), K101433 (d5), K120370 (d5), K073291 (d5), K083026 (d5), K103731 (d5), K112405 (d5), K092211 (d5), K120031 (d5), K122630 (d5), K112028 (d5), K130092 (d5), K090064 (d5), K110733 (d5), K113518 (d5), K071724 (d5), K102957 (d5), K120368 (d5), K081611 (d5), K140003 (d5), K140921 (d5), K142050 (d5), K142264 (d5), K100945 (d5), K110843 (d5), K112316 (d5), K113138 (d5), K113561 (d5), K130699 (d5), K141405 (d5), K060506 (d5), K123486 (d5), K132624 (d5), K143393 (d5), K143616 (d5), K141049 (d5), K150714 (d5), K150875 (d5), K151718 (d5), K152681 (d5), K080401 (d6), K040166 (d6), K082500 (d6), K933785 (d6), K943462 (d6), K961685 (d6), K090648 (d6), K102257 (d6), P950002 (d6), K073351 (d6), K082260 (d6), K051454 (d6), K063399 (d6), K080024 (d6), K080699 (d6), K011182 (d6), K070387 (d6), K073562 (d6), K080313 (d6), K102249 (d6), K083626 (d6), K083894 (d6), K073202 (d6), K062083 (d6), K072253 (d6), K083475 (d6), K033926 (d6), K071795 (d6), K090353 (d6), K094025 (d6), K103662 (d6), K080971 (d6), K092070 (d6), K072160 (d6), K031672 (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), K123206 (d6), K081968 (d6), K100089 (d6), K131372 (d6), K130177 (d6), K053340 (d6), K100391 (d6), K052261 (d7), P950019 (d7), K042871 (d7), K052888 (d7), K062174 (d7), K101229 (d7), K050539 (d7), K063423 (d7), K974556 (d7), K043479 (d7), K091508 (d8), K093846 (d8) — cited as predicate by K223146, K231689, K232878

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

Manufacturer compliance record — Foundation Fusion Solutions, LLC

Nothing in the loaded window.