Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K260294
Device Name SF Push-in Anchor
Applicant
Surgical Fusion Technologies GmbH
Wagistrasse 6
Schlieren,  CH 8952
Applicant Contact Mayer Joerg
Correspondent
Hogan Lovells US LLP
1735 Market St.
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Codes
GAT   HTY  
Date Received01/29/2026
Decision Date 03/27/2026
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
-
-