The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Osteomed External Mandibular Distraction System.
| Device ID | K063792 |
| 510k Number | K063792 |
| Device Name: | OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Contact | Piedad Pena |
| Correspondent | Piedad Pena OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2007-03-02 |
| Summary: | summary |