Clearance Summary
TBW received FDA 510(k) clearance under submission number K010545, sponsored by Tri-Med, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2001-06-06.
- Submission: K010545
- Applicant / Sponsor: Tri-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2001-06-06
Classification & Regulation
This clearance is catalogued under FDA product code NDL and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.