K113339 is an FDA 510(k) clearance for the ORTHOLOC 3DSI LOCKING SCREWS. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on December 12, 2011, 28 days after receiving the submission on November 14, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K113339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2011 |
| Decision Date | December 12, 2011 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |