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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K240288
Device Name SF Push- in Anchor
Applicant
Surgical Fusion Technologies GmbH
Wagistrasse 6
Schlieren,  CH 8952
Applicant Contact Joerg Mayer
Correspondent
Hogan Lovells US LLP
1735 Market St.,
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Payne Kelli
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
GAT   HTY   HWC   NKB  
Date Received02/01/2024
Decision Date 04/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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