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FDA 510(k)

LINK Embrace Shoulder System - Reverse Configuration

K-Number: K200368 · 2021-02-05

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2021-02-05
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK Embrace Shoulder System - Reverse Configuration is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2021-02-05 under approval number K200368. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK Embrace Shoulder System - Reverse Configuration?

LINK Embrace Shoulder System - Reverse Configuration is a medical device that received FDA 510(k) clearance on 2021-02-05. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K200368.

When was LINK Embrace Shoulder System - Reverse Configuration approved by the FDA?

LINK Embrace Shoulder System - Reverse Configuration received FDA 510(k) clearance on 2021-02-05, under approval number K200368.

What company makes LINK Embrace Shoulder System - Reverse Configuration?

LINK Embrace Shoulder System - Reverse Configuration is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for LINK Embrace Shoulder System - Reverse Configuration?

The FDA product code for LINK Embrace Shoulder System - Reverse Configuration is PHX.

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Waldemar Link GmbH & Co. KG

K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated K171273LINK® BiMobile(TM) Dual Mobility System K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System) K190535BiMobile Dual Mobility System - E-Dur Inserts K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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