The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Osteomed Subtalar Implant System.
| Device ID | K031155 |
| 510k Number | K031155 |
| Device Name: | OSTEOMED SUBTALAR IMPLANT SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Contact | Dawn T Holdeman |
| Correspondent | Dawn T Holdeman OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-11 |
| Decision Date | 2003-08-22 |
| Summary: | summary |