K132363 is an FDA 510(k) clearance for the DOLPHIX 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 Citieffe S.R.L. (Ormond Beach, US). The FDA issued a Cleared decision on January 16, 2014, 170 days after receiving the submission on July 30, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K132363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2013 |
| Decision Date | January 16, 2014 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | KTT - Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |