The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Reunion Ha Fracture Stem.
| Device ID | K070963 |
| 510k Number | K070963 |
| Device Name: | REUNION HA FRACTURE STEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Francisco Haro |
| Correspondent | Francisco Haro 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 | 2007-04-05 |
| Decision Date | 2007-05-04 |
| Summary: | summary |