The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Futura Biomedical Flexible Great Toe Implant.
| Device ID | K981194 |
| 510k Number | K981194 |
| Device Name: | FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | NEXA ORTHOPEDICS, INC. 9369 CARROLL PARK DR., SUITE A San Diego, CA 92121 |
| Contact | Jamal D Rushy |
| Correspondent | Jamal D Rushy NEXA ORTHOPEDICS, INC. 9369 CARROLL PARK DR., SUITE A San Diego, CA 92121 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-02 |
| Decision Date | 1998-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780257431 | K981194 | 000 |
| 10381780257738 | K981194 | 000 |
| 10381780257721 | K981194 | 000 |
| 10381780257714 | K981194 | 000 |
| 10381780257707 | K981194 | 000 |
| 00885556834435 | K981194 | 000 |
| 00885556834411 | K981194 | 000 |
| 00885556834398 | K981194 | 000 |
| 00885556834374 | K981194 | 000 |