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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K260011
Device Name Foundation Surgical Navigated Lateral Disc Prep Instruments
Applicant
Foundation Surgical Group, Inc.
7327 E Tierra Buena Ln.
Suite 101
Scottsdale,  AZ  85260
Applicant Contact Asher Breverman
Correspondent
Applied Technical Services (Empirical Technologies)
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/02/2026
Decision Date 04/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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