The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Mandible External Fixator.
| Device ID | K040169 |
| 510k Number | K040169 |
| 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 | 2004-01-26 |
| Decision Date | 2004-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980043051030 | K040169 | 000 |
| H980043050030 | K040169 | 000 |
| H980043050040 | K040169 | 000 |
| H980043050050 | K040169 | 000 |
| H980043050100 | K040169 | 000 |
| H980043050110 | K040169 | 000 |
| H980043050120 | K040169 | 000 |
| H980043051000 | K040169 | 000 |
| H980043051010 | K040169 | 000 |
| H980043051020 | K040169 | 000 |
| H980033050060 | K040169 | 000 |