Clearance Summary
PSL ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance under submission number K103819, sponsored by Precision Surgery , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-02-15.
- Submission: K103819
- Applicant / Sponsor: Precision Surgery , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2011-02-15
Classification & Regulation
This clearance is catalogued under FDA product code KWQ and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.