K111077 is an FDA 510(k) clearance for the ORTHOSORB RESORBABLE PINS. This device is classified as a Pin, Fixation, Resorbable, Hard Tissue (Class II - Special Controls, product code OVZ).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 12, 2011, 85 days after receiving the submission on April 18, 2011.
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 | K111077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2011 |
| Decision Date | July 12, 2011 |
| Days to Decision | 85 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. |