ZIP™ MIS Interspinous Fusion System

Spinous Process Plate

Aurora Spine, Inc.

The following data is part of a premarket notification filed by Aurora Spine, Inc. with the FDA for Zip™ Mis Interspinous Fusion System.

Pre-market Notification Details

Device IDK221399
510k NumberK221399
Device Name:ZIP™ MIS Interspinous Fusion System
ClassificationSpinous Process Plate
Applicant Aurora Spine, Inc. 1930 Palomar Point Way, Suite #103 Carlsbad,  CA  92008
ContactLaszlo Garamszegi
CorrespondentJustin Eggleton
MCRA LLC 803 7th Street NW Washington DC,  DC  20001
Product CodePEK  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-13
Decision Date2022-07-08

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