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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 Interlaminal
510(k) Number K871870
Device Name HSC UNIT ROD
Applicant
Research Development Corp.
88 Elm St.
Toronto
Canada,  CA M5G 1X8
Applicant Contact BARBARA LAVERS
Correspondent
Research Development Corp.
88 Elm St.
Toronto
Canada,  CA M5G 1X8
Correspondent Contact BARBARA LAVERS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received05/13/1987
Decision Date 07/21/1987
Decision Substantially Equivalent (SESE)
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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