Adverse-event reports (MAUDE)
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.
Recall history
No recalls linked.
Regulatory clearances
Predicate lineage
- K192003
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.
Manufacturer compliance record
None in the loaded window.
Similar devices
- Liaison poignée-clou Ø12 / Nail/Handle connection Ø12 FOURNITURES HOSPITALIERES INDUSTRIE
- "9/32"" HEX SCREWDRIVER, SHORT" ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- "K-Wire, 1.6mm x 12"", Trocar/Spade Tip, Flex-Thread™" FLOWER ORTHOPEDICS CORPORATION
- "K-Wire, 1.6mm x 8"", Trocar Tip" FLOWER ORTHOPEDICS CORPORATION
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/3 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
- 1/4 TUBULAR PLATE - COLLARED Biomet Orthopedics, LLC
Select up to two to place side-by-side with this device.