510(k) K171592
K171592 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver". The FDA issued a decision of Substantially Equivalent on Aug 29, 2017. 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
- Aug 29, 2017
- Date Received
- May 31, 2017
- 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)