K102601 is an FDA 510(k) clearance for the ORTHOFLEX ROD. This device is classified as a Prosthesis, Toe, Constrained, Polymer (Class II — Special Controls, product code KWH).
Submitted by Ortho-Pro, LLC (Round Rock, US). The FDA issued a Cleared decision on January 14, 2011, 127 days after receiving the submission on September 9, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3720.
| 510(k) Number | K102601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2010 |
| Decision Date | January 14, 2011 |
| Days to Decision | 127 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 |