Clearance Summary
osteo-WEDGE II ® Open Wedge Bone Locking Plate System received FDA 510(k) clearance under submission number K162179, sponsored by Graham Medical Technologies, LLC Dba Gramedica. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-01-10.
- Submission: K162179
- Applicant / Sponsor: Graham Medical Technologies, LLC Dba Gramedica
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2017-01-10
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.