The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Nexa Carpo Metacarpal Implant.
| Device ID | K060386 |
| 510k Number | K060386 |
| Device Name: | NEXA CARPO METACARPAL IMPLANT |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | NEXA ORTHOPEDICS, INC. 10675 SORRENTO VALLEY ROAD SUITE 100 San Diego, CA 92121 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht NEXA ORTHOPEDICS, INC. 10675 SORRENTO VALLEY ROAD SUITE 100 San Diego, CA 92121 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2006-05-10 |
| Summary: | summary |