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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 K945022
Device Name APOFIX CERVICAL SPINE FIXATION
Applicant
Sofamor Co.
60, 62 Rue Rothschild
Berck/Mer,  FR 62600
Applicant Contact BRIAN GOODEN
Correspondent
Sofamor Co.
60, 62 Rue Rothschild
Berck/Mer,  FR 62600
Correspondent Contact BRIAN GOODEN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received10/13/1994
Decision Date 05/15/1995
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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