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: K113733, K120807, K160553, K160946, K171108, K192003, K201336, K201346
Cited as predicate by: K111667, K131609, K143245, K160553, K171108, K180436, K191617, K192003, K193308, K201336, K210285, K230071
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.
- 3.3mm Screw Fastener Self Tapping 14mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 16mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 18mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 20mm Osteocentric Technologies, Inc.
- 4.0 x 22mm LOCKING BONE SCREW FASTENER ST Osteocentric Technologies, Inc.
- AJAX Nail Auxein Medical Private Limited
- AJAX Nail Auxein Medical Private Limited
- AJAX Nail Auxein Medical Private Limited
- AJAX Nail Auxein Medical Private Limited
- AJAX Nail Auxein Medical Private Limited
- AJAX Nail Auxein Medical Private Limited
- AJAX Nail Auxein Medical Private Limited