Panels › Orthopedic › Product code PHX · Class 2
Shoulder Prosthesis, Reverse Configuration
Regulation 888.3660
18510(k)s in 12 months (207 all time)
12recalls in 12 months (69 all time)
69recalls that name a 510(k)
Top companies in PHX
| Company | 510(k)s | Recalls |
|---|---|---|
| Exactech, Inc. | 21 | 23 |
| Encore Medical L.P. | 18 | 16 |
| Tornier | 18 | 3 |
| Biomet Manufacturing Corp | 15 | 0 |
| Zimmer GmbH | 10 | 5 |
| DePuy Orthopaedics, Inc. | 6 | 8 |
| Medacta International S.A. | 13 | 0 |
| Arthrex, Inc. | 11 | 0 |
| Lima Corporate S.P.A. | 11 | 0 |
| Biomet Corporation | 4 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 2005 | K051075 | ENCORE REVERSE SHOULDER PROSTHESIS Encore Medical L.P. | PHX |
| May 16, 2005 | K050315 | DELTA HUMERAL CUPS DePuy Orthopaedics, Inc. | PHX |
| Mar 24, 2005 | K041066 | ENCORE REVERSE SHOULDER PROSTHESIS Encore Medical L.P. | PHX |
| Mar 16, 2005 | K050316 | AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier, FR | PHX |
| Aug 25, 2004 | K041873 | AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier, FR | PHX |
| May 14, 2004 | K030941 | AEQUALIS REVERSED SHOULDER PROSTHESIS Tornier | PHX |
| Nov 18, 2003 | K021478 | DELTA SHOULDER Depuy, Inc. | PHX |
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