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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
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