Panels › Orthopedic › Product code KWS · Class 2
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Regulation 888.3660
3510(k)s in 12 months (191 all time)
4recalls in 12 months (153 all time)
131recalls that name a 510(k)
Top companies in KWS
| Company | 510(k)s | Recalls |
|---|---|---|
| Encore Medical L.P. | 9 | 35 |
| Exactech, Inc. | 8 | 23 |
| Tornier | 24 | 6 |
| Zimmer GmbH | 7 | 20 |
| Biomet, Inc. | 4 | 21 |
| DePuy Orthopaedics, Inc. | 9 | 11 |
| Tournier, Inc. | 0 | 18 |
| Smith & Nephew, Inc. | 11 | 6 |
| Arthrex, Inc. | 15 | 0 |
| Lima Corporate S.P.A. | 8 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640. Terminated |
KWS | K022377 K031449 |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046. Terminated |
KWS | K022377 K031449 |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000. Terminated |
KWS | K022377 K031449 |
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