The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Hemi-shoulder Prosthesis.
| Device ID | K950594 |
| 510k Number | K950594 |
| Device Name: | HEMI-SHOULDER PROSTHESIS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | J. D Webb |
| Correspondent | J. D Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-09 |
| Decision Date | 1995-05-22 |