The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Plasma Sprayed Shoulder.
| Device ID | K003324 |
| 510k Number | K003324 |
| Device Name: | PLASMA SPRAYED SHOULDER |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Joanna Droege |
| Correspondent | Joanna Droege ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-24 |
| Decision Date | 2001-12-06 |