Clearance Summary
SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM received FDA 510(k) clearance under submission number K113405, sponsored by Suspension Orthopaedic Solutions, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-01-11.
- Submission: K113405
- Applicant / Sponsor: Suspension Orthopaedic Solutions, LLC
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2012-01-11
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.