CO VERTEBRAL BODY REPLACEMENT

Spinal Vertebral Body Replacement Device

SCIENT'X

The following data is part of a premarket notification filed by Scient'x with the FDA for Co Vertebral Body Replacement.

Pre-market Notification Details

Device IDK050348
510k NumberK050348
Device Name:CO VERTEBRAL BODY REPLACEMENT
ClassificationSpinal Vertebral Body Replacement Device
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 CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-11
Decision Date2005-05-27
Summary:summary

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