The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Mini External Fixator.
| Device ID | K961350 |
| 510k Number | K961350 |
| Device Name: | SYNTHES MINI EXTERNAL FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| 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 | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-05 |
| Decision Date | 1996-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792927080 | K961350 | 000 |
| H6793959020 | K961350 | 000 |
| H6793953040 | K961350 | 000 |
| H6793953020 | K961350 | 000 |
| H6793951390 | K961350 | 000 |