The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Subtalar Peg Implant.
| Device ID | K033046 |
| 510k Number | K033046 |
| Device Name: | SUBTALAR PEG IMPLANT |
| Classification | Prosthesis, Subtalar, Plug, Polymer |
| Applicant | NEXA ORTHOPEDICS, INC. 990 PARK CENTER DR., SUITE H Vista, CA 92083 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht NEXA ORTHOPEDICS, INC. 990 PARK CENTER DR., SUITE H Vista, CA 92083 |
| Product Code | MJW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-12-23 |
| Summary: | summary |