The Gecko Spinal System

Bone Fixation Cerclage, Sublaminar

Ortho Development Corporation

The following data is part of a premarket notification filed by Ortho Development Corporation with the FDA for The Gecko Spinal System.

Pre-market Notification Details

Device IDK200281
510k NumberK200281
Device Name:The Gecko Spinal System
ClassificationBone Fixation Cerclage, Sublaminar
Applicant Ortho Development Corporation 12187 South Business Park Drive Draper,  UT  84020
ContactDivya Palan
CorrespondentDivya Palan
Ortho Development Corporation 12187 South Business Park Drive Draper,  UT  84020
Product CodeOWI  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-04
Decision Date2020-03-31
Summary:summary

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