SOFAMOR ORFIL SPINE FIXATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

SOFAMOR CO.

The following data is part of a premarket notification filed by Sofamor Co. with the FDA for Sofamor Orfil Spine Fixation System.

Pre-market Notification Details

Device IDK934007
510k NumberK934007
Device Name:SOFAMOR ORFIL SPINE FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SOFAMOR CO. 158 RUE DE L'ENGLISE B.P. 4 RANG-DU-FLIERS 62180 France,  FR
ContactBrian Gooden
CorrespondentBrian Gooden
SOFAMOR CO. 158 RUE DE L'ENGLISE B.P. 4 RANG-DU-FLIERS 62180 France,  FR
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-18
Decision Date1994-06-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20681490717254 K934007 000
20673978017826 K934007 000
20673978017758 K934007 000
20613994346227 K934007 000

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