The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Mandible External Fixator.
| Device ID | K050378 |
| 510k Number | K050378 |
| Device Name: | SYNTHES MANDIBLE EXTERNAL FIXATOR |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-15 |
| Decision Date | 2005-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679394990 | K050378 | 000 |
| H980033051050 | K050378 | 000 |
| H980033055000 | K050378 | 000 |
| H980043051280 | K050378 | 000 |
| H980043051300 | K050378 | 000 |
| H980043051340 | K050378 | 000 |
| H980043051380 | K050378 | 000 |
| H980043051400 | K050378 | 000 |
| H980043051420 | K050378 | 000 |
| H679292790 | K050378 | 000 |
| H679392240 | K050378 | 000 |
| H980SD4490100 | K050378 | 000 |