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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K110990
Device Name GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Gold Standard Orthopedics, LLC
3415 N. Old Farm Rd. E.
Warsaw,  IN  46582
Applicant Contact JAMES RITTER
Correspondent
Gold Standard Orthopedics, LLC
3415 N. Old Farm Rd. E.
Warsaw,  IN  46582
Correspondent Contact JAMES RITTER
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/08/2011
Decision Date 07/25/2011
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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