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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 K894702
Device Name STUART CD UNIVERSAL ROD CONNECTOR CLAMPS
Applicant
Bio-Medical Prosthetics
5600 Silver Oak Ct.
Rockville,  MD  20855
Applicant Contact ABE GLASSER
Correspondent
Bio-Medical Prosthetics
5600 Silver Oak Ct.
Rockville,  MD  20855
Correspondent Contact ABE GLASSER
Regulation Number888.3050
Classification Product Code
KWP  
Date Received07/27/1989
Decision Date 10/11/1989
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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