Tritanium PL Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

Stryker

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

Pre-market Notification Details

Device IDK152304
510k NumberK152304
Device Name:Tritanium PL Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Stryker 2 PEARL COURT Allendale,  NJ  07401
ContactSimona Voic
CorrespondentSimona Voic
Stryker 2 PEARL COURT Allendale,  NJ  07401
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-14
Decision Date2015-11-19
Summary:summary

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