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FDA 510(k)

AGILON® XO Shoulder Replacement System

K-Number: K191433 · 2020-11-12

ApplicantImplantcast GmbH
Decision Date2020-11-12
Product CodeHSD
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 2020-11-12 under 510(k) number K191433. The device is classified under product code HSD. 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 2020-11-12. The listed applicant is Implantcast GmbH. The 510(k) number is K191433.

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

AGILON® XO Shoulder Replacement System received FDA 510(k) clearance on 2020-11-12, under 510(k) number K191433.

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 HSD.

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: HSD)

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.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.K161620Anatomical Shoulder Domelock Dome centricZimmer 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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