K100707 is an FDA 510(k) clearance for the REPROCESSED PINS. This device is classified as a Pin, Fixation, Threaded, Metallic (Class II — Special Controls, product code NDM).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 25, 2010, 105 days after receiving the submission on March 12, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K100707 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | March 12, 2010 |
| Decision Date | June 25, 2010 |
| Days to Decision | 105 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | NDM — Pin, Fixation, Threaded, Metallic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3040 |