The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Solar Purefix Ha Shoulder.
| Device ID | K061677 |
| 510k Number | K061677 |
| Device Name: | SOLAR PUREFIX HA SHOULDER |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Tiffani Rogers |
| Correspondent | Tiffani Rogers HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-15 |
| Decision Date | 2006-07-10 |
| Summary: | summary |