Tritanium PL Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

Stryker Spine

The following data is part of a premarket notification filed by Stryker Spine with the FDA for Tritanium Pl Cage.

Pre-market Notification Details

Device IDK181014
510k NumberK181014
Device Name:Tritanium PL Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Stryker Spine 2 Pearl Court Allendale,  NJ  07401
ContactTravis Catania
CorrespondentTravis Catania
Stryker Spine 2 Pearl Court Allendale,  NJ  07401
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-17
Decision Date2018-07-18
Summary:summary

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