MODIFICATION TO ALTIUS OCT SYSTEM

Appliance, Fixation, Spinal Interlaminal

INTERPORE CROSS INTL.

The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Modification To Altius Oct System.

Pre-market Notification Details

Device IDK043229
510k NumberK043229
Device Name:MODIFICATION TO ALTIUS OCT SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine,  CA  92618 -2402
ContactWendy Spielberger
CorrespondentWendy Spielberger
INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine,  CA  92618 -2402
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-22
Decision Date2004-12-21
Summary:summary

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