Hoffmann LRF (Limb Reconstruction Frame) 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 (limb Reconstruction Frame) System.

Pre-market Notification Details

Device IDK153377
510k NumberK153377
Device Name:Hoffmann LRF (Limb Reconstruction Frame) System
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactPaul Nelson
CorrespondentPaul Nelson
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-23
Decision Date2016-04-11
Summary:summary

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