The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Osteomed Resurfacing Metatarsal Implant With Hydroxylapatite Coating.
| Device ID | K081876 |
| 510k Number | K081876 |
| Device Name: | OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Contact | Alma Relja |
| Correspondent | Alma Relja OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-02 |
| Decision Date | 2008-08-01 |
| Summary: | summary |