K032058 is an FDA 510(k) clearance for the MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II - Special Controls, product code KTT).
Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on July 30, 2003, 28 days after receiving the submission on July 2, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K032058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2003 |
| Decision Date | July 30, 2003 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |