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TiLink-L Navigation Inserter Hexalobe Driver

Model SR21-6304 · Surgentec, LLC · DI 00810131882563

OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560

UDILibrary device dossier · generated 2026-09-15 · 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.

25792019-01: 0 reports for this device; peer average 2.67/device2019-02: 0 reports for this device; peer average 3.61/device2019-03: 0 reports for this device; peer average 3.19/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 3.1/device2019-06: 0 reports for this device; peer average 2.72/device2019-07: 0 reports for this device; peer average 3.23/device2019-08: 0 reports for this device; peer average 2.93/device2019-09: 0 reports for this device; peer average 2.89/device2019-10: 0 reports for this device; peer average 3.84/device2019-11: 0 reports for this device; peer average 5.54/device2019-12: 0 reports for this device; peer average 3.54/device2020-01: 0 reports for this device; peer average 3.39/device2020-02: 0 reports for this device; peer average 4.56/device2020-03: 0 reports for this device; peer average 4.41/device2020-04: 0 reports for this device; peer average 7.69/device2020-05: 0 reports for this device; peer average 2.37/device2020-06: 0 reports for this device; peer average 3.54/device2020-07: 0 reports for this device; peer average 3.94/device2020-08: 0 reports for this device; peer average 2.61/device2020-09: 0 reports for this device; peer average 3.93/device2020-10: 0 reports for this device; peer average 5.63/device2020-11: 0 reports for this device; peer average 5.77/device2020-12: 0 reports for this device; peer average 4.33/device2021-01: 0 reports for this device; peer average 4.68/device2021-02: 0 reports for this device; peer average 4.08/device2021-03: 0 reports for this device; peer average 3.82/device2021-04: 0 reports for this device; peer average 3.82/device2021-05: 0 reports for this device; peer average 4.15/device2021-06: 0 reports for this device; peer average 3.79/device2021-07: 0 reports for this device; peer average 3.25/device2021-08: 0 reports for this device; peer average 2.96/device2021-09: 0 reports for this device; peer average 2.92/device2021-10: 0 reports for this device; peer average 2.27/device2021-11: 0 reports for this device; peer average 4.24/device2021-12: 0 reports for this device; peer average 2.72/device2022-01: 0 reports for this device; peer average 2.54/device2022-02: 0 reports for this device; peer average 3.16/device2022-03: 0 reports for this device; peer average 3.32/device2022-04: 0 reports for this device; peer average 2.45/device2022-05: 0 reports for this device; peer average 3.91/device2022-06: 0 reports for this device; peer average 4.21/device2022-07: 0 reports for this device; peer average 3.33/device2022-08: 0 reports for this device; peer average 2.9/device2022-09: 0 reports for this device; peer average 2.32/device2022-10: 0 reports for this device; peer average 3.76/device2022-11: 0 reports for this device; peer average 3.44/device2022-12: 0 reports for this device; peer average 4.22/device2023-01: 0 reports for this device; peer average 3.18/device2023-02: 0 reports for this device; peer average 3.44/device2023-03: 0 reports for this device; peer average 3.77/device2023-04: 0 reports for this device; peer average 3.26/device2023-05: 0 reports for this device; peer average 3.02/device2023-06: 0 reports for this device; peer average 2.6/device2023-07: 0 reports for this device; peer average 2.69/device2023-08: 0 reports for this device; peer average 2.51/device2023-09: 0 reports for this device; peer average 4.04/device2023-10: 0 reports for this device; peer average 3.21/device2023-11: 0 reports for this device; peer average 9.13/device2023-12: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 3.71/device2024-02: 0 reports for this device; peer average 4.15/device2024-03: 0 reports for this device; peer average 4.4/device2024-04: 0 reports for this device; peer average 3.95/device2024-05: 0 reports for this device; peer average 4.89/device2024-06: 0 reports for this device; peer average 4.54/device2024-07: 0 reports for this device; peer average 3.92/device2024-08: 0 reports for this device; peer average 4.59/device2024-09: 0 reports for this device; peer average 4.53/device2024-10: 0 reports for this device; peer average 6.31/device2024-11: 0 reports for this device; peer average 4.74/device2024-12: 0 reports for this device; peer average 4.01/device2025-01: 0 reports for this device; peer average 8.37/device2025-02: 0 reports for this device; peer average 4.23/device2025-03: 0 reports for this device; peer average 3.59/device2025-04: 0 reports for this device; peer average 4.2/device2025-05: 0 reports for this device; peer average 4.57/device2025-06: 0 reports for this device; peer average 4.14/device2025-07: 0 reports for this device; peer average 4.32/device2025-08: 0 reports for this device; peer average 5.03/device2025-09: 0 reports for this device; peer average 3.85/device2025-10: 0 reports for this device; peer average 3.97/device2025-11: 0 reports for this device; peer average 4.12/device2025-12: 0 reports for this device; peer average 4.59/device2026-01: 0 reports for this device; peer average 4.53/device2026-02: 0 reports for this device; peer average 4.25/device2026-03: 0 reports for this device; peer average 4.08/device2026-04: 0 reports for this device; peer average 3.9/device2026-05: 0 reports for this device; peer average 4.99/device2026-06: 0 reports for this device; peer average 3.99/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.67
2019-0203.61
2019-0303.19
2019-0402.75
2019-0503.1
2019-0602.72
2019-0703.23
2019-0802.93
2019-0902.89
2019-1003.84
2019-1105.54
2019-1203.54
2020-0103.39
2020-0204.56
2020-0304.41
2020-0407.69
2020-0502.37
2020-0603.54
2020-0703.94
2020-0802.61
2020-0903.93
2020-1005.63
2020-1105.77
2020-1204.33
2021-0104.68
2021-0204.08
2021-0303.82
2021-0403.82
2021-0504.15
2021-0603.79
2021-0703.25
2021-0802.96
2021-0902.92
2021-1002.27
2021-1104.24
2021-1202.72
2022-0102.54
2022-0203.16
2022-0303.32
2022-0402.45
2022-0503.91
2022-0604.21
2022-0703.33
2022-0802.9
2022-0902.32
2022-1003.76
2022-1103.44
2022-1204.22
2023-0103.18
2023-0203.44
2023-0303.77
2023-0403.26
2023-0503.02
2023-0602.6
2023-0702.69
2023-0802.51
2023-0904.04
2023-1003.21
2023-1109.13
2023-1204
2024-0103.71
2024-0204.15
2024-0304.4
2024-0403.95
2024-0504.89
2024-0604.54
2024-0703.92
2024-0804.59
2024-0904.53
2024-1006.31
2024-1104.74
2024-1204.01
2025-0108.37
2025-0204.23
2025-0303.59
2025-0404.2
2025-0504.57
2025-0604.14
2025-0704.32
2025-0805.03
2025-0903.85
2025-1003.97
2025-1104.12
2025-1204.59
2026-0104.53
2026-0204.25
2026-0304.08
2026-0403.9
2026-0504.99
2026-0603.99
This device (reports/month)Average device in OLO (reports/device/month)

Regulatory clearances

  • K253604 SESE 2026-03-20 (k number procode)

Predicate lineage

K253604 — cites (transitively): K161210 (d1), K231831 (d1), K243265 (d1), K243580 (d1), K110472 (d2), K111520 (d2), K124004 (d2), K131405 (d2), K140454 (d2), K150231 (d2), K230446 (d2), K211855 (d2), K241416 (d2), K170675 (d2), K180937 (d2), K021932 (d3), K051296 (d3), K080398 (d3), K092375 (d3), K102903 (d3), K110838 (d3), K914004 (d3), K061113 (d3), K061639 (d3), K063305 (d3), K081475 (d3), K050438 (d3), K123850 (d3), K131425 (d3), K142611 (d3), K142661 (d3), K161568 (d3), K132126 (d3), K163374 (d3), K112028 (d3), K150017 (d3), K240086 (d3), K122074 (d4), K073291 (d4), K083026 (d4), K103731 (d4), K112405 (d4), K130943 (d4), K132699 (d4), K121476 (d4), K141245 (d4), K092568 (d4), K120340 (d4), K131417 (d4), K201900 (d4), K052043 (d5), K100154 (d5), K063091 (d5), K003928 (d5), K021705 (d5), K953076 (d5), K131007 (d5), K200431 (d5), K012773 (d6), K071420 (d6)

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