STELLA CERVICAL PLATE

Appliance, Fixation, Spinal Intervertebral Body

SCIENT'X

The following data is part of a premarket notification filed by Scient'x with the FDA for Stella Cervical Plate.

Pre-market Notification Details

Device IDK052763
510k NumberK052763
Device Name:STELLA CERVICAL PLATE
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SCIENT'X 1001 OAKWOOD BLVD Round Rock,  TX  78681
ContactJ. D. Webb
CorrespondentJ. D. Webb
SCIENT'X 1001 OAKWOOD BLVD Round Rock,  TX  78681
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-30
Decision Date2005-11-10
Summary:summary

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