SIMMETRY SACROILIAC JOINT FUSION SYSTEM

Sacroiliac Joint Fixation

Zyga Technology, Inc.

The following data is part of a premarket notification filed by Zyga Technology, Inc. with the FDA for Simmetry Sacroiliac Joint Fusion System.

Pre-market Notification Details

Device IDK110512
510k NumberK110512
Device Name:SIMMETRY SACROILIAC JOINT FUSION SYSTEM
ClassificationSacroiliac Joint Fixation
Applicant Zyga Technology, Inc. 700 10TH AVENUE SOUTH, SUITE 400 Minneapolis,  MN  55415
ContactDiane Brinza
CorrespondentDiane Brinza
Zyga Technology, Inc. 700 10TH AVENUE SOUTH, SUITE 400 Minneapolis,  MN  55415
Product CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-23
Decision Date2011-03-23
Summary:summary

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