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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K261809
Device Name Interwedge® Standalone Lateral
Applicant
Foundation Surgical Group
7327 E Tierra Buena Ln.
Suite 101
Scottsdale,  AZ  85260
Applicant Contact Asher Breverman
Correspondent
Foundation Surgical Group
7327 E Tierra Buena Ln.
Suite 101
Scottsdale,  AZ  85260
Correspondent Contact Christopher Reah
Regulation Number888.3080
Classification Product Code
OVD  
Date Received06/01/2026
Decision Date 07/31/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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