LINK Embrace Shoulder System - Reverse Configuration

Shoulder Prosthesis, Reverse Configuration

Waldemar Link GmbH & Co. KG

The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Embrace Shoulder System - Reverse Configuration.

Pre-market Notification Details

Device IDK200368
510k NumberK200368
Device Name:LINK Embrace Shoulder System - Reverse Configuration
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Waldemar Link GmbH & Co. KG Ostsraße 4-10 Norderstedt,  DE 22844
ContactStephanie Fuchs
CorrespondentTerry Powell
Link Bio Corp. 69 King Street Dover,  NJ  07801
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodePAO
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-14
Decision Date2021-02-05

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