Clearance Summary
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN received FDA 510(k) clearance under submission number K121018, sponsored by Smith & Nephew, 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 2012-06-22.
- Submission: K121018
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2012-06-22
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.