SCIENT'X SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

SCIENT'X

The following data is part of a premarket notification filed by Scient'x with the FDA for Scient'x Spinal System.

Pre-market Notification Details

Device IDK062912
510k NumberK062912
Device Name:SCIENT'X SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
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 CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-27
Decision Date2007-02-05
Summary:summary

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