K081586 is an FDA 510(k) clearance for the REPROCESSED EXTERNAL FIXATION DEVICE. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II - Special Controls, product code KTT).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 18, 2008, 74 days after receiving the submission on June 5, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K081586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2008 |
| Decision Date | August 18, 2008 |
| Days to Decision | 74 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 |