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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 K843445
Device Name SACRAL BAR
Applicant
Stuart
One Stuart Plz.
Donohue/Luxor Rd.S
Greensburg,  PA  15601
Applicant Contact ABRAHAM GLASSER
Correspondent
Stuart
One Stuart Plz.
Donohue/Luxor Rd.S
Greensburg,  PA  15601
Correspondent Contact ABRAHAM GLASSER
Regulation Number888.3050
Classification Product Code
KWP  
Date Received09/05/1984
Decision Date 02/13/1985
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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