Clearance Summary
GPS Spacers received FDA 510(k) clearance under submission number K142456, sponsored by G Surgical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-04-10.
- Submission: K142456
- Applicant / Sponsor: G Surgical, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2015-04-10
Classification & Regulation
This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.