ART POSTERIOR SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

ADVANCED MEDICAL TECHNOLOGIES AG

The following data is part of a premarket notification filed by Advanced Medical Technologies Ag with the FDA for Art Posterior Spinal System.

Pre-market Notification Details

Device IDK033150
510k NumberK033150
Device Name:ART POSTERIOR SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant ADVANCED MEDICAL TECHNOLOGIES AG 1001 OAKWOOD BLVD. Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
ADVANCED MEDICAL TECHNOLOGIES AG 1001 OAKWOOD BLVD. Round Rock,  TX  78681
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-30
Decision Date2004-03-01
Summary:summary

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