510(k) K260294

SF Push-in Anchor by Surgical Fusion Technologies GmbH — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2026
Date Received
January 29, 2026
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