K052037 is an FDA 510(k) clearance for the MODIFICATION TO HOFFMANN II MICRO 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 Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on August 5, 2005, 8 days after receiving the submission on July 28, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K052037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2005 |
| Decision Date | August 05, 2005 |
| Days to Decision | 8 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 |