MODIFICATION TO SYNTHES CERVIFIX SYSTEM

Orthosis, Spinal Pedicle Fixation

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK030377
510k NumberK030377
Device Name:MODIFICATION TO SYNTHES CERVIFIX SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactVikki M Hoffman
CorrespondentVikki M Hoffman
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-05
Decision Date2003-03-06
Summary:summary

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