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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 K934007
Device Name SOFAMOR ORFIL SPINE FIXATION SYSTEM
Applicant
Sofamor Co.
158 Rue De L'Englise
B.P. 4 Rang-Du-Fliers 62180
France,  FR
Applicant Contact BRIAN GOODEN
Correspondent
Sofamor Co.
158 Rue De L'Englise
B.P. 4 Rang-Du-Fliers 62180
France,  FR
Correspondent Contact BRIAN GOODEN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received08/18/1993
Decision Date 06/02/1994
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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