K022886 is an FDA 510(k) clearance for the METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM. This device is classified as a Prosthesis, Toe, Constrained, Polymer (Class II - Special Controls, product code KWH).
Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on November 25, 2002, 87 days after receiving the submission on August 30, 2002.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3720.
| 510(k) Number | K022886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2002 |
| Decision Date | November 25, 2002 |
| Days to Decision | 87 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 |