The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Traumafix (tm) External Fixator.
| Device ID | K914558 |
| 510k Number | K914558 |
| Device Name: | TRAUMAFIX (TM) EXTERNAL FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Diane Cochet-wynant |
| Correspondent | Diane Cochet-wynant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 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 | 1991-10-15 |
| Decision Date | 1992-01-16 |