DAYTONA ANTERIOR CERVICAL CAGE

Intervertebral Fusion Device With Bone Graft, Cervical

SPINENET, LLC

The following data is part of a premarket notification filed by Spinenet, Llc with the FDA for Daytona Anterior Cervical Cage.

Pre-market Notification Details

Device IDK110733
510k NumberK110733
Device Name:DAYTONA ANTERIOR CERVICAL CAGE
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant SPINENET, LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
ContactJ.d. Webb
CorrespondentJ.d. Webb
SPINENET, LLC 1001 OAKWOOD BLVD Round Rock,  TX  78681
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-16
Decision Date2011-08-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B047CTRC1400 K110733 000
B047CL1214080 K110733 000
B047CL1214070 K110733 000
B047CL1214060 K110733 000
B047CL1214050 K110733 000
B047CL1012100 K110733 000
B047CL1012090 K110733 000
B047CL1012080 K110733 000
B047CL1012070 K110733 000
B047CL1012060 K110733 000
B047CL1012050 K110733 000
B047CINS1100 K110733 000
B047CGRP1300 K110733 000
B047CL1214090 K110733 000
B047CL1214100 K110733 000
B047CTL1214100 K110733 000
B047CTL1214090 K110733 000
B047CTL1214080 K110733 000
B047CTL1214070 K110733 000
B047CTL1214060 K110733 000
B047CTL1214050 K110733 000
B047CTL1012100 K110733 000
B047CTL1012090 K110733 000
B047CTL1012080 K110733 000
B047CTL1012070 K110733 000
B047CTL1012060 K110733 000
B047CTL1012050 K110733 000
B047CGRB1200 K110733 000

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