K243308 is an FDA 510(k) clearance for the Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste). This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Bonebridge AG (Zug, CH). The FDA issued a Cleared decision on December 20, 2024, 60 days after receiving the submission on October 21, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K243308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2024 |
| Decision Date | December 20, 2024 |
| Days to Decision | 60 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 |