The following data is part of a premarket notification filed by Osteomed Lp with the FDA for Osteomed Smartflex Cranial Spring Distractor.
| Device ID | K123885 |
| 510k Number | K123885 |
| Device Name: | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR |
| Classification | Cranial Distraction System |
| Applicant | OSTEOMED LP 3885 Arapaho Rd Addison, TX 75001 |
| Contact | Piedad Pena |
| Correspondent | Piedad Pena OSTEOMED LP 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 | 2012-12-18 |
| Decision Date | 2013-06-03 |
| Summary: | summary |