The following data is part of a premarket notification filed by Avanta Orthopaedics, Inc. with the FDA for Wrist Implant.
| Device ID | K021859 |
| 510k Number | K021859 |
| Device Name: | WRIST IMPLANT |
| Classification | Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| Applicant | AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A San Diego, CA 92121 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A San Diego, CA 92121 |
| Product Code | JWJ |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-06 |
| Decision Date | 2002-12-02 |
| Summary: | summary |