The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Subtalar Arthrorisis Implant.
| Device ID | K032902 |
| 510k Number | K032902 |
| Device Name: | SUBTALAR ARTHRORISIS IMPLANT |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2003-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832006335 | K032902 | 000 |
| 00846832006328 | K032902 | 000 |
| 00846832006311 | K032902 | 000 |
| 00846832006304 | K032902 | 000 |
| 00846832006298 | K032902 | 000 |
| 00846832006281 | K032902 | 000 |