510(k) K180274

Ventix Link Knotless Anchor with Inserter by Cayenne Medical, Inc. — Product Code MBI

K180274 is an FDA 510(k) premarket notification submitted by Cayenne Medical, Inc. for the device "Ventix Link Knotless Anchor with Inserter". The FDA issued a decision of Substantially Equivalent on March 21, 2018. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Cayenne Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2018
Date Received
January 31, 2018
Clearance Type
Traditional
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