The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Ratcheting Distractor.
| Device ID | K981275 |
| 510k Number | K981275 |
| Device Name: | SYNTHES (USA) RATCHETING DISTRACTOR |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-08 |
| Decision Date | 1998-06-25 |
| Summary: | summary |