SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (u.s.a.)universal Spinal Parellel Connector The Universal Spinal Rod And Screw Fixation System.

Pre-market Notification Details

Device IDK964416
510k NumberK964416
Device Name:SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
ContactDiane T Brown
CorrespondentDiane T Brown
SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-04
Decision Date1997-03-17
Summary:summary

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