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FDA 510(k)

LINK Embrace Shoulder System- Anatomical Configuration

K-Number: K210899 · 2021-06-21

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2021-06-21
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK Embrace Shoulder System- Anatomical Configuration is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2021-06-21 under approval number K210899. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK Embrace Shoulder System- Anatomical Configuration?

LINK Embrace Shoulder System- Anatomical Configuration is a medical device that received FDA 510(k) clearance on 2021-06-21. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K210899.

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

LINK Embrace Shoulder System- Anatomical Configuration received FDA 510(k) clearance on 2021-06-21, under approval number K210899.

What company makes LINK Embrace Shoulder System- Anatomical Configuration?

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

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

The FDA product code for LINK Embrace Shoulder System- Anatomical Configuration is KWT.

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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) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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)

View all 29 devices →

Related Devices (Code: KWT)

K161476SMR Shoulder SystemLima Corporate S.P.A. K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc. K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, 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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