K010847 is an FDA 510(k) clearance for the K'FIX. This device is classified as a Pin, Fixation, Smooth, Metallic (Class II - Special Controls, product code NDL).
Submitted by Avanta Orthopaedics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 19, 2001, 90 days after receiving the submission on March 21, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K010847 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2001 |
| Decision Date | June 19, 2001 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDL — Pin, Fixation, Smooth, Metallic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |