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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 K250167
Device Name Evolution Spine Navigation Instruments
Applicant
Evolution Spine
2300 N. Haskell Ave.
Dallas,  TX  75204
Applicant Contact James Mirda
Correspondent
Evolution Spine
2300 N. Haskell Ave.
Dallas,  TX  75204
Correspondent Contact James Mirda
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/21/2025
Decision Date 08/18/2025
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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