MX MONOAXIAL PEDICLE SCREW

Orthosis, Spondylolisthesis Spinal Fixation

SCIENT'X

The following data is part of a premarket notification filed by Scient'x with the FDA for Mx Monoaxial Pedicle Screw.

Pre-market Notification Details

Device IDK042964
510k NumberK042964
Device Name:MX MONOAXIAL PEDICLE SCREW
ClassificationOrthosis, Spondylolisthesis Spinal 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 CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-27
Decision Date2004-11-22
Summary:summary

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