K051306 is an FDA 510(k) clearance for the HOFFMANN II MRI EXTERNAL FIXATION SYSTEM. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (Class II - Special Controls, product code LXT).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on June 17, 2005, 29 days after receiving the submission on May 19, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K051306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2005 |
| Decision Date | June 17, 2005 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LXT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |