Clearance Summary
PLLA, HA SCREW received FDA 510(k) clearance under submission number K080358, 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 2008-04-23.
- Submission: K080358
- 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: 2008-04-23
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.