ISS INTEGRATED SPINE SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

ORTHO DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Iss Integrated Spine System.

Pre-market Notification Details

Device IDK061524
510k NumberK061524
Device Name:ISS INTEGRATED SPINE SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper,  UT  84020
ContactWilliam J Griffin
CorrespondentWilliam J Griffin
ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper,  UT  84020
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-02
Decision Date2006-09-26

NIH GUDID Devices

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