Clearance Summary
Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants received FDA 510(k) clearance under submission number K221468, sponsored by Acuitive Technologies, 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 2023-02-14.
- Submission: K221468
- Applicant / Sponsor: Acuitive Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2023-02-14
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.