K140625 is an FDA 510(k) clearance for the ORTHOSORB LS. This device is classified as a Pin, Fixation, Resorbable, Hard Tissue (Class II - Special Controls, product code OVZ).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 18, 2014, 38 days after receiving the submission on March 11, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Intended For Small Bone Fixation In Fracture, Osteotomy, And Arthrodesis Applications..
| 510(k) Number | K140625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2014 |
| Decision Date | April 18, 2014 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OVZ — Pin, Fixation, Resorbable, Hard Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |
| Definition | Intended For Small Bone Fixation In Fracture, Osteotomy, And Arthrodesis Applications. |