The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Lesser Metatarsal Phalangeal Joint Implant.
| Device ID | K023531 |
| 510k Number | K023531 |
| Device Name: | LESSER METATARSAL PHALANGEAL JOINT 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-21 |
| Decision Date | 2003-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780257455 | K023531 | 000 |
| 10381780257691 | K023531 | 000 |
| 10381780257684 | K023531 | 000 |
| 10381780257677 | K023531 | 000 |
| 10381780257660 | K023531 | 000 |
| 00885556834596 | K023531 | 000 |
| 00885556834572 | K023531 | 000 |
| 00885556834558 | K023531 | 000 |
| 00885556834534 | K023531 | 000 |