510(k) K233971

Arthrex AlloSync PushLock Suture Anchor by Arthrex, Inc. — Product Code MAI

K233971 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex AlloSync PushLock Suture Anchor". The FDA issued a decision of Substantially Equivalent on June 4, 2024. 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
June 4, 2024
Date Received
December 15, 2023
Clearance Type
Traditional
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