K240461 is an FDA 510(k) clearance for the OsteoSinter® EVANS and COTTON wedges and related accessories. This device is classified as a Bone Wedge (Class II - Special Controls, product code PLF).
Submitted by Ames Medical Prosthetic Solutions, S.A.U. (Sant Feliu De Llobregat, ES). The FDA issued a Cleared decision on December 6, 2024, 294 days after receiving the submission on February 16, 2024.
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 | K240461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2024 |
| Decision Date | December 06, 2024 |
| Days to Decision | 294 days |
| Submission Type | Abbreviated |
| 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. |