MACROPORE HYDROSORB SPINE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

MACROPORE BIOSURGERY, INC.

The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Hydrosorb Spine System.

Pre-market Notification Details

Device IDK041105
510k NumberK041105
Device Name:MACROPORE HYDROSORB SPINE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego,  CA  92121
ContactKenneth Kleinhenz
CorrespondentKenneth Kleinhenz
MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego,  CA  92121
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-30
Decision Date2004-07-28
Summary:summary

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