The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Modification To Classic Great Toe Implant.
| Device ID | K023562 |
| 510k Number | K023562 |
| Device Name: | MODIFICATION TO CLASSIC GREAT TOE IMPLANT |
| Classification | Prosthesis, Toe, Constrained, 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 | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-23 |
| Decision Date | 2002-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780257653 | K023562 | 000 |
| 00885556834268 | K023562 | 000 |
| 00885556834282 | K023562 | 000 |
| 00885556834305 | K023562 | 000 |
| 00885556834329 | K023562 | 000 |
| 10381780257479 | K023562 | 000 |
| 10381780257615 | K023562 | 000 |
| 10381780257622 | K023562 | 000 |
| 10381780257639 | K023562 | 000 |
| 10381780257646 | K023562 | 000 |
| 00885556834244 | K023562 | 000 |