K061599 is an FDA 510(k) clearance for the PIN SCREW. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Bk Meditech, Co., Ltd. (Hwasung-Si, Kyunggi-Do, KR). The FDA issued a Cleared decision on July 26, 2006, 48 days after receiving the submission on June 8, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K061599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2006 |
| Decision Date | July 26, 2006 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDW - Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |