RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW— 510(k) K130550

Clearance details

Applicant

Encore Medical L.P.

Product code

Code PHX

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2013-03-04

Decision date

2014-03-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Austin, TX, US

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• K251776 — EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)2025-07-08

Death

10

Injury

9,705

Malfunction

1,252

Total

10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →