The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Locking Reconstruction Plate (lrp) With Condylar Head.
| Device ID | K990637 |
| 510k Number | K990637 |
| Device Name: | SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD |
| Classification | Prosthesis, Condyle, Mandibular, Temporary |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Angela Silvestri |
| Correspondent | Angela Silvestri SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | NEI |
| CFR Regulation Number | 872.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-26 |
| Decision Date | 1999-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9804496490 | K990637 | 000 |
| H9804496480 | K990637 | 000 |
| H9804496470 | K990637 | 000 |
| H9804496460 | K990637 | 000 |
| H9804496450 | K990637 | 000 |
| H9804496440 | K990637 | 000 |