The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European UnionB-03701037310601B-03701037310601
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.
- 510(k)K192206Substantially equivalent (SESE) · 2019-10-08clearance family
Predicate lineage
Cited as predicate by: K193394
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
- 10 Deg 36mm Adj B-D Mini Sizer Biomet Orthopedics, LLC
- 3 Peg Mod Drill Guide Sz 1 Zimmer, Inc.
- 3 Peg Mod Drill Guide Sz 2-5 Zimmer, Inc.
- 3PEGS GLENOID CEMENT PRESSURIZER LIMACORPORATE SPA
- 3PEGS GLENOID CEMENT PRESSURIZER LIMACORPORATE SPA
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC
- ABSOLUTE BI-POLAR SHOULDER SYSTEM Biomet Orthopedics, LLC