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TiLink-L Screw Drill Bit - 8mm 3D Printed

Model SR21-6205 · Surgentec, LLC · DI 00810131880507

OUR — Sacroiliac Joint Fixation · Class II · 21 CFR 888.3040

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.

358102019-01: 0 reports for this device; peer average 2.8/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 2.29/device2019-04: 0 reports for this device; peer average 2.13/device2019-05: 0 reports for this device; peer average 2.08/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2.09/device2019-08: 0 reports for this device; peer average 2.5/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 2.43/device2019-11: 0 reports for this device; peer average 1.86/device2019-12: 0 reports for this device; peer average 1.83/device2020-01: 0 reports for this device; peer average 2.25/device2020-02: 0 reports for this device; peer average 3.14/device2020-03: 0 reports for this device; peer average 1.71/device2020-04: 0 reports for this device; peer average 1.33/device2020-05: 0 reports for this device; peer average 2.5/device2020-06: 0 reports for this device; peer average 2.14/device2020-07: 0 reports for this device; peer average 3/device2020-08: 0 reports for this device; peer average 2.2/device2020-09: 0 reports for this device; peer average 2.75/device2020-10: 0 reports for this device; peer average 2.5/device2020-11: 0 reports for this device; peer average 2.33/device2020-12: 0 reports for this device; peer average 2.22/device2021-01: 0 reports for this device; peer average 1.82/device2021-02: 0 reports for this device; peer average 2.4/device2021-03: 0 reports for this device; peer average 2.6/device2021-04: 0 reports for this device; peer average 1.92/device2021-05: 0 reports for this device; peer average 2.44/device2021-06: 0 reports for this device; peer average 1.8/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 3.75/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1.56/device2021-11: 0 reports for this device; peer average 2.18/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 3/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 1.75/device2022-08: 0 reports for this device; peer average 3/device2022-12: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 2.67/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 1.86/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2.33/device2025-02: 0 reports for this device; peer average 4/device2025-03: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 10/device2025-11: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040507081203040607080203040508091011120102030506070809101101020304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.8
2019-0202
2019-0302.29
2019-0402.13
2019-0502.08
2019-0602
2019-0702.09
2019-0802.5
2019-0902
2019-1002.43
2019-1101.86
2019-1201.83
2020-0102.25
2020-0203.14
2020-0301.71
2020-0401.33
2020-0502.5
2020-0602.14
2020-0703
2020-0802.2
2020-0902.75
2020-1002.5
2020-1102.33
2020-1202.22
2021-0101.82
2021-0202.4
2021-0302.6
2021-0401.92
2021-0502.44
2021-0601.8
2021-0702
2021-0803.75
2021-0902
2021-1001.56
2021-1102.18
2021-1202
2022-0102
2022-0203
2022-0303
2022-0402
2022-0503
2022-0701.75
2022-0803
2022-1203
2023-0303
2023-0402.67
2023-0603
2023-0702
2023-0801
2024-0201.5
2024-0302
2024-0402
2024-0501.67
2024-0801.86
2024-0902
2024-1002
2024-1102
2024-1202
2025-0102.33
2025-0204
2025-0302
2025-0502
2025-0602
2025-0701
2025-0802
2025-0901.67
2025-10010
2025-1102
2026-0102
2026-0201.5
2026-0302
2026-0402
This device (reports/month)Average device in OUR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K230446 — cites (transitively): K112028 (d1), K150017 (d1), K021932 (d2), K122074 (d2), K080398 (d3), K092375 (d3) — cited as predicate by K231831, K243835

K231831 — cites (transitively): K230446 (d1), K112028 (d2), K150017 (d2), K021932 (d3), K122074 (d3), K080398 (d4), K092375 (d4) — cited as predicate by K243835, K253604

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

Manufacturer compliance record — Surgentec, LLC

  • NAI 2022-12-14 SurGenTec, LLC · 0 citations
  • NAI 2022-12-14 SurGenTec, LLC · 0 citations
  • VAI 2019-04-18 SurGenTec, LLC · 3 citations
  • VAI 2019-04-18 SurGenTec, LLC · 3 citations