510(k) K221099

Arthrex Self-Punching PushLock Suture Anchor by Arthrex, Inc. — Product Code MAI

K221099 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Self-Punching PushLock Suture Anchor". The FDA issued a decision of Substantially Equivalent on May 13, 2022. 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 352 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2022
Date Received
Apr 14, 2022
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
510(k)