510(k) K200725
K200725 is an FDA 510(k) premarket notification submitted by Acuitive Technologies for the device "Citregen Tendon Interference Screw and Citrelock". The FDA issued a decision of Substantially Equivalent on October 7, 2020. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Acuitive Technologies has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2020
- Date Received
- March 19, 2020
- 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