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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K071274
Device Name GSO GS1 SPACER
Applicant
Gold Standard Orthopedics, LLC
1226 Rowan St.
Louisville,  KY  40203
Applicant Contact DAVID BAUGHMAN
Correspondent
Gold Standard Orthopedics, LLC
1226 Rowan St.
Louisville,  KY  40203
Correspondent Contact DAVID BAUGHMAN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received05/07/2007
Decision Date 08/24/2007
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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