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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 K241487
Device Name Interwedge® Standalone Lateral
Applicant
Foundation Surgical Group, Inc.
7327 E Tierra Buena Lane
Suite 101
Scottsdale,  AZ  85260
Applicant Contact Asher Breverman
Correspondent
Empirical Technologies
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received05/24/2024
Decision Date 10/02/2024
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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