SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE 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 Spine Small Stature Anterior Cervical Vertebrae Plate System.

Pre-market Notification Details

Device IDK971883
510k NumberK971883
Device Name:SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SYNTHES (USA) P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
ContactBarry E Sands
CorrespondentBarry E Sands
SYNTHES (USA) P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-22
Decision Date1997-10-16
Summary:summary

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