The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sterile Mandible External Fixation Kit.
| Device ID | K062299 |
| 510k Number | K062299 |
| Device Name: | SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-08 |
| Decision Date | 2006-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98003305500S0 | K062299 | 000 |