The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Solar 2 Anatomic Shoulder.
| Device ID | K040432 |
| 510k Number | K040432 |
| Device Name: | SOLAR 2 ANATOMIC SHOULDER |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Ginny Stamberger |
| Correspondent | Ginny Stamberger STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-19 |
| Decision Date | 2005-01-07 |
| Summary: | summary |