510(k) K251145

Arthrex PushLock Suture Anchors by Arthrex, Inc. — Product Code MBI

K251145 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex PushLock Suture Anchors". The FDA issued a decision of Substantially Equivalent on July 10, 2025. 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
July 10, 2025
Date Received
April 14, 2025
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