510(k) K262357

Arthrex Bioabsorbable PushLock Suture Anchors by Arthrex, Inc. — Product Code MAI

K262357 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Bioabsorbable PushLock Suture Anchors". The FDA issued a decision of Substantially Equivalent on August 7, 2026. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Arthrex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2026
Date Received
July 10, 2026
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