The following data is part of a premarket notification filed by Osteomed with the FDA for Osteomed Cranial Distraction System.
| Device ID | K121304 |
| 510k Number | K121304 |
| Device Name: | OSTEOMED CRANIAL DISTRACTION SYSTEM |
| Classification | Cranial Distraction System |
| Applicant | OSTEOMED 3885 Arapaho Rd Addison, TX 75001 |
| Contact | Piedad Pena |
| Correspondent | Piedad Pena OSTEOMED 3885 Arapaho Rd Addison, TX 75001 |
| Product Code | PBJ |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-01 |
| Decision Date | 2012-08-22 |
| Summary: | summary |