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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 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 2021-02-05 under 510(k) 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. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K200368.

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

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

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

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

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: PHX)

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.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet 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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