Clearance Summary
GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + received FDA 510(k) clearance under submission number K103070, sponsored by G Surgical Co., 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 2011-01-12.
- Submission: K103070
- Applicant / Sponsor: G Surgical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2011-01-12
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.