Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
No recalls linked.
Predicate lineage
Cited as predicate by: K133606, K140324, K141263, K151004, K153186, K170440, K173278, K200028, K203121, K211770, K220260, K220650, K231857, K233531, K242091
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
None in the loaded window.
- Container FOURNITURES HOSPITALIERES INDUSTRIE
- Pin guide cannula FOURNITURES HOSPITALIERES INDUSTRIE
- 10mm x 10mm Staple System Trilliant Surgical, LLC
- 10mm x 10mm x 10mm Staple Trilliant Surgical, LLC
- 12mm STEP STAPLE 15X20-2X2 BIOPRO, INC.
- 12mm STEP STAPLE 20X20-2X3 BIOPRO, INC.
- 12mm x 12mm x 12mm Staple Trilliant Surgical, LLC
- 15mm x 12mm x 12mm Staple Trilliant Surgical, LLC
- 15mm x 15mm x 15mm Staple Trilliant Surgical, LLC
- 18mm x 15mm x 15mm Staple Trilliant Surgical, LLC
- 18mm x 18mm x 18mm Staple Trilliant Surgical, LLC
- 2.9 X 12.5mm Citrefix XPress System Acuitive Technologies, Inc.