Clearance Summary
ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER received FDA 510(k) clearance under submission number K961649, sponsored by Smith & Nephew Endoscopy, 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 1996-07-16.
- Submission: K961649
- Applicant / Sponsor: Smith & Nephew Endoscopy, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1996-07-16
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.