PELVIS II IMPLANT SYSTEM

Plate, Fixation, Bone

Stryker Trauma AG

The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for Pelvis Ii Implant System.

Pre-market Notification Details

Device IDK131132
510k NumberK131132
Device Name:PELVIS II IMPLANT SYSTEM
ClassificationPlate, Fixation, Bone
Applicant Stryker Trauma AG 325 Corporate Drive Mahwah,  NJ  07430
ContactElijah Wreh
CorrespondentElijah Wreh
Stryker Trauma AG 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-23
Decision Date2013-05-31
Summary:summary

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