Altus Spine Titanium Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Lumbar

Altus Partners, LLC

The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Altus Spine Titanium Interbody Fusion System.

Pre-market Notification Details

Device IDK170512
510k NumberK170512
Device Name:Altus Spine Titanium Interbody Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Altus Partners, LLC 1340 Enterprise Drive West Chester,  PA  19380
ContactClaudia Hill
CorrespondentClaudia Hill
Altus Partners, LLC 1340 Enterprise Drive West Chester,  PA  19380
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-21
Decision Date2017-03-10
Summary:summary

NIH GUDID Devices

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