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: K102924, K120794, K131135, K131633, K162726, K173824, K182516, K183039, K191963, K193038, K202024, K202716, K210899, K212737, K241817
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.
- TT MB Peg LIMACORPORATE SPA
- TT MB Peg LIMACORPORATE SPA
- +9MM FUZ PADDLE REV Zimmer, Inc.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- """PROFEMUR®" Microport Orthopedics Inc.