VIRAGE OCT SPINAL FIXATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

ZIMMER SPINE, INC.

The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Virage Oct Spinal Fixation System.

Pre-market Notification Details

Device IDK133556
510k NumberK133556
Device Name:VIRAGE OCT SPINAL FIXATION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439
ContactHolly Seppanen
CorrespondentHolly Seppanen
ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis,  MN  55439
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-19
Decision Date2014-06-02
Summary:summary

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