K981194 is an FDA 510(k) clearance for the FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT. This device is classified as a Prosthesis, Toe, Constrained, Polymer (Class II - Special Controls, product code KWH).
Submitted by Nexa Orthopedics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 30, 1998, 89 days after receiving the submission on April 2, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3720.
| 510(k) Number | K981194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1998 |
| Decision Date | June 30, 1998 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWH — Prosthesis, Toe, Constrained, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3720 |