Hoffmann LRF System

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

Stryker GmbH

The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Hoffmann Lrf System.

Pre-market Notification Details

Device IDK182968
510k NumberK182968
Device Name:Hoffmann LRF System
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactJackie Perri
CorrespondentJackie Perri
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-26
Decision Date2019-01-25
Summary:summary

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