The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Osteomed 1st Mpj Hemi Implant System.
| Device ID | K060536 |
| 510k Number | K060536 |
| Device Name: | OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| 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 | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-28 |
| Decision Date | 2006-06-02 |
| Summary: | summary |