The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Medium External Fixation System-mr Safe.
| Device ID | K040258 |
| 510k Number | K040258 |
| Device Name: | SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE |
| 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 | 2004-02-04 |
| Decision Date | 2004-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6793900360 | K040258 | 000 |
| H6793900340 | K040258 | 000 |
| H6793900330 | K040258 | 000 |
| H6793900320 | K040258 | 000 |
| H6793900370 | K040258 | 000 |
| H6793900350 | K040258 | 000 |
| H6793900310 | K040258 | 000 |