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FDA 510(k)

AGILON® XO Shoulder Replacement System

K-Number: K231657 · 2024-02-16

ApplicantImplantcast GmbH
Decision Date2024-02-16
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AGILON® XO Shoulder Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K231657. 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 AGILON® XO Shoulder Replacement System?

AGILON® XO Shoulder Replacement System is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Implantcast GmbH. The 510(k) number is K231657.

When did AGILON® XO Shoulder Replacement System receive FDA 510(k) clearance?

AGILON® XO Shoulder Replacement System received FDA 510(k) clearance on 2024-02-16, under 510(k) number K231657.

Who is the listed applicant for AGILON® XO Shoulder Replacement System?

The FDA 510(k) record lists Implantcast GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGILON® XO Shoulder Replacement System?

The FDA product code for AGILON® XO Shoulder Replacement System is KWT.

Other records listing Implantcast GmbH 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.

K252451EPORE® XO cup systemK260037implantcast Packaging System UpdateK252401implaFit® short stemsK241944AGILON® XO Shoulder Replacement SystemK240391MUTARS® femoral stem cemented 160 mm and 200 mmK234044ACS® LD FB Knee System

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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.K223631Comprehensive Segmental Revision System(SRS)Biomet OrthopedicsK222482AGILON XO Shoulder SystemImplantcast GmbH

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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