K131413 is an FDA 510(k) clearance for the XTRAFIX SMALL EXTERNAL FIXATION SYSTEM. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II - Special Controls, product code KTT).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 28, 2014, 257 days after receiving the submission on May 16, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K131413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2013 |
| Decision Date | January 28, 2014 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |