K012645 is an FDA 510(k) clearance for the REPROCESSED EBI EXTERNAL FIXATION DEVICES. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Single Component (Class II - Special Controls, product code KTW).
Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on June 24, 2002, 315 days after receiving the submission on August 13, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K012645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2001 |
| Decision Date | June 24, 2002 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KTW — Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |