K130008 is an FDA 510(k) clearance for the DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by I.T.S. GmbH (Prior Lake, US). The FDA issued a Cleared decision on June 25, 2013, 174 days after receiving the submission on January 2, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K130008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2013 |
| Decision Date | June 25, 2013 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| 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 |