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 IDK141549
510k NumberK141549
Device Name:SImmetry Sacroiliac Joint Fusion System
ClassificationSacroiliac Joint Fixation
Applicant Zyga Technology, Inc. 5600 Rowland Rd Suite 200 Minnetonka,  MN  55343
ContactDiane Brinza
CorrespondentDiane Brinza
Zyga Technology, Inc. 5600 Rowland Rd Suite 200 Minnetonka,  MN  55343
Product CodeOUR  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-11
Decision Date2015-01-15
Summary:summary

NIH GUDID Devices

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