K043113 is an FDA 510(k) clearance for the TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II - Special Controls, product code KTT).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 21, 2005, 72 days after receiving the submission on November 10, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K043113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2004 |
| Decision Date | January 21, 2005 |
| Days to Decision | 72 days |
| Submission Type | Abbreviated |
| 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 |