510(k) K180763
K180763 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "CuffLink Implant System Biocomposite". The FDA issued a decision of Substantially Equivalent on Jul 19, 2018. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Conmed Corporation has 82 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 19, 2018
- Date Received
- Mar 23, 2018
- 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
- 510(k)