510(k) K232592
K232592 is an FDA 510(k) premarket notification submitted by Acuitive Technologies, Inc. for the device "CITRELOCK® DUO". The FDA issued a decision of Substantially Equivalent on September 20, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Acuitive Technologies, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2023
- Date Received
- August 25, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type