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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 K240160
Device Name EGPS Navigated Instruments
Applicant
Astura Medical
4949 W. Royal Ln.
Irving,  TX  75063
Applicant Contact Parker Kelch
Correspondent
Astura Medical
4949 W. Royal Ln.
Irving,  TX  75063
Correspondent Contact Parker Kelch
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/19/2024
Decision Date 10/17/2024
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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