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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 K873977
Device Name NEW C-D SYSTEM FOR SPINAL SURGERY
Applicant
Sofamor Co.
One Stuart Plz.
Donohue/Luxor Rd.S
Greensburg,  PA  15601
Applicant Contact ABRAHAM GLASSER
Correspondent
Sofamor Co.
One Stuart Plz.
Donohue/Luxor Rd.S
Greensburg,  PA  15601
Correspondent Contact ABRAHAM GLASSER
Regulation Number888.3060
Classification Product Code
JDN  
Date Received09/29/1987
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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