THOR ANTERIOR PLATING SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

STRYKER SPINE

The following data is part of a premarket notification filed by Stryker Spine with the FDA for Thor Anterior Plating System.

Pre-market Notification Details

Device IDK080773
510k NumberK080773
Device Name:THOR ANTERIOR PLATING SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
ContactCurtis Truesdale
CorrespondentCurtis Truesdale
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-19
Decision Date2008-06-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327067453 K080773 000
07613327067316 K080773 000
07613327067323 K080773 000
07613327067330 K080773 000
07613327067347 K080773 000
07613327067354 K080773 000
07613327067361 K080773 000
07613327067378 K080773 000
07613327067385 K080773 000
07613327067392 K080773 000
07613327067408 K080773 000
07613327067415 K080773 000
07613327067422 K080773 000
07613327067439 K080773 000
07613327067446 K080773 000
07613327067309 K080773 000

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