ALEUTIAN IBF SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Aleutian Ibf System.

Pre-market Notification Details

Device IDK082698
510k NumberK082698
Device Name:ALEUTIAN IBF SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant K2M, INC. 751 MILLER DR.,SE Leesburg,  VA  20175
ContactRichard Woods
CorrespondentRichard Woods
K2M, INC. 751 MILLER DR.,SE Leesburg,  VA  20175
Product CodeMAX  
Subsequent Product CodeMQP
Subsequent Product CodeODP
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-15
Decision Date2009-04-21
Summary:summary

NIH GUDID Devices

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