SYNTHES CERVIFIX/ AXON

Appliance, Fixation, Spinal Interlaminal

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cervifix/ Axon.

Pre-market Notification Details

Device IDK023675
510k NumberK023675
Device Name:SYNTHES CERVIFIX/ AXON
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactVikki M Hoffman
CorrespondentVikki M Hoffman
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-01
Decision Date2002-11-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9814989140 K023675 000

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