K151256 is an FDA 510(k) clearance for the Arthrex BioSync® Bone Wedge. This device is classified as a Bone Wedge (Class II - Special Controls, product code PLF).
Submitted by Arthex, Inc. (Naples, US). The FDA issued a Cleared decision on August 12, 2015, 92 days after receiving the submission on May 12, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030. Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia..
| 510(k) Number | K151256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2015 |
| Decision Date | August 12, 2015 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PLF - Bone Wedge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
| Definition | Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia. |