The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 9usa) Alveolar Ridge Distractor.
| Device ID | K043555 |
| 510k Number | K043555 |
| Device Name: | SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson 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 | 2004-12-27 |
| Decision Date | 2005-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587056128 | K043555 | 000 |
| 10887587056111 | K043555 | 000 |
| 10887587056104 | K043555 | 000 |