Clearance Summary
GENESYS PRESSFT SUTURE ANCHOR received FDA 510(k) clearance under submission number K121890, sponsored by Linvatec Corporation D/B/A Conmed Linvatec. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-08-22.
- Submission: K121890
- Applicant / Sponsor: Linvatec Corporation D/B/A Conmed Linvatec
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2012-08-22
Classification & Regulation
This clearance is catalogued under FDA product code MAI and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.