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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 the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2021-06-21 under 510(k) 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. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K210899.

When did LINK Embrace Shoulder System- Anatomical Configuration receive FDA 510(k) clearance?

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

Who is the listed applicant for LINK Embrace Shoulder System- Anatomical Configuration?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Waldemar Link GmbH & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KWT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbHK223631Comprehensive Segmental Revision System(SRS)Biomet Orthopedics

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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