Clearance Summary
GPS, G SURGICAL PEDICLE SYSTEM received FDA 510(k) clearance under submission number K081041, 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 2008-06-27.
- Submission: K081041
- Applicant / Sponsor: G Surgical Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2008-06-27
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.