Prosthesis, Condyle, Mandibular, Temporary
Regulation 872.4770
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NEI
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes (Usa) | 3 | 0 |
| KLS-Martin L.P. | 1 | 0 |
| Osteomed LP | 1 | 0 |
| Stryker | 1 | 0 |
| Walter Lorenz Surgical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2014 | K133285 | STRYKER TEMPORARY CONDYLAR PROSTHESIS Stryker | NEI |
| Sep 5, 2008 | K081747 | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM Synthes (Usa) | NEI |
| Jan 5, 2007 | K063181 | SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM Synthes (Usa) | NEI |
| Jul 8, 2004 | K031701 | OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM Osteomed LP | NEI |
| Aug 6, 2001 | K002790 | ADD-ON CONDYLE Walter Lorenz Surgical, Inc. | NEI |
| Jul 27, 2001 | K990667 | KLS-MARTIN TEMPORARY CONDYLAR IMPLANT KLS-Martin L.P. | NEI |
| Oct 22, 1999 | K990637 | SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD Synthes (Usa) | NEI |
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