510(k) K232973

Arthrex Knee FiberTak® Button Suture Anchor by Arthrex, Inc. — Product Code MBI

K232973 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Knee FiberTak® Button Suture Anchor". The FDA issued a decision of Substantially Equivalent on November 15, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Arthrex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2023
Date Received
September 21, 2023
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