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2.4mm/3.0mm Gridlock Screw Countersink
Model 310-30-002 · Trilliant Surgical, LLC · DI 00812926023915
HWW — Countersink · Class I · 21 CFR 888.4540
UDILibrary device dossier · generated 2026-09-14 · 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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-07 | 0 | 1 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — Trilliant Surgical, LLC
- Warning Letter 2010-05-03 Trilliant Surgical, LLC
- Warning Letter 2010-05-03 Trilliant Surgical, LLC
- VAI 2019-12-11 Trilliant Surgical, LLC · 5 citations
- VAI 2019-12-11 Trilliant Surgical, LLC · 5 citations
- VAI 2018-05-02 Trilliant Surgical, LLC · 10 citations
- VAI 2018-05-02 Trilliant Surgical, LLC · 10 citations
- OAI 2016-06-27 Trilliant Surgical, LLC · 9 citations
- OAI 2016-06-27 Trilliant Surgical, LLC · 9 citations
- OAI 2015-02-12 Trilliant Surgical, LLC · 5 citations
- OAI 2015-02-12 Trilliant Surgical, LLC · 5 citations
- VAI 2011-09-09 Trilliant Surgical, LLC · 3 citations
- VAI 2011-09-09 Trilliant Surgical, LLC · 3 citations
- OAI 2010-01-20 Trilliant Surgical, LLC · 4 citations
- OAI 2010-01-20 Trilliant Surgical, LLC · 4 citations