Clearance Summary
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM received FDA 510(k) clearance under submission number K101206, sponsored by Alexandria Research Technologies, 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 2010-07-23.
- Submission: K101206
- Applicant / Sponsor: Alexandria Research Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3520
- Decision date: 2010-07-23
Classification & Regulation
This clearance is catalogued under FDA product code HSX and 21 CFR 888.3520, within the Orthopedic review panel as a Class II device.