Clearance Summary
SMITH & NEPHEW PEEK INTERFERENCE SCREW received FDA 510(k) clearance under submission number K083226, 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 2009-01-30.
- Submission: K083226
- Applicant / Sponsor: Smith & Nephew Endoscopy, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2009-01-30
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.