510(k) K170501

CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver by Conmed Corporation — Product Code MAI

K170501 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 Mar 17, 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
Mar 17, 2017
Date Received
Feb 21, 2017
Clearance Type
Special
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)