RABEA SPINAL IMPLANT

Spinal Vertebral Body Replacement Device

SIGNUS MEDIZINTECHNIK GMBH

The following data is part of a premarket notification filed by Signus Medizintechnik Gmbh with the FDA for Rabea Spinal Implant.

Pre-market Notification Details

Device IDK043316
510k NumberK043316
Device Name:RABEA SPINAL IMPLANT
ClassificationSpinal Vertebral Body Replacement Device
Applicant SIGNUS MEDIZINTECHNIK GMBH 4050 OLSON MEMORIAL HWY SUITE 350 Minneapolis,  MN  55422
ContactTracy L Gray
CorrespondentTracy L Gray
SIGNUS MEDIZINTECHNIK GMBH 4050 OLSON MEMORIAL HWY SUITE 350 Minneapolis,  MN  55422
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-02
Decision Date2005-02-07
Summary:summary

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