Clearance Summary
Tenodesis screw system received FDA 510(k) clearance under submission number K151701, sponsored by Normed Medizin-Technik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-01-26.
- Submission: K151701
- Applicant / Sponsor: Normed Medizin-Technik GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2016-01-26
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.