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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Fixation Device, Spinal
510(k) Number K872715
Device Name UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
Applicant
Roseburg SA
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Applicant Contact DARIENNE MOYER
Correspondent
Roseburg SA
Suite 120 Canal Sq.
1054 31st St. NW
Washington,  DC  20007
Correspondent Contact DARIENNE MOYER
Regulation Number888.3060
Classification Product Code
JDN  
Date Received07/10/1987
Decision Date 12/07/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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