510(k) K221468
K221468 is an FDA 510(k) premarket notification submitted by Acuitive Technologies, Inc. for the device "Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants". The FDA issued a decision of Substantially Equivalent on February 14, 2023. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Acuitive Technologies, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2023
- Date Received
- May 20, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type