Clearance Summary
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM received FDA 510(k) clearance under submission number K093943, sponsored by Smith & Nephew Inc., Endoscopy Div.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-03-05.
- Submission: K093943
- Applicant / Sponsor: Smith & Nephew Inc., Endoscopy Div.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2010-03-05
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.