Clearance Summary
TransLoc 3D received FDA 510(k) clearance under submission number K211496, sponsored by Foundation Fusion Solutions, LLC (Dba Cornerloc). The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-07-27.
- Submission: K211496
- Applicant / Sponsor: Foundation Fusion Solutions, LLC (Dba Cornerloc)
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2022-07-27
Classification & Regulation
This clearance is catalogued under FDA product code OUR and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.