Clearance Summary
AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS received FDA 510(k) clearance under submission number K110176, sponsored by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-02-15.
- Submission: K110176
- Applicant / Sponsor: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2011-02-15
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.