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FDA 510(k)

Exactech® Equinoxe® Stemless Humeral Components

K-Number: K192097 · 2020-04-29

ApplicantExactech, Inc.
Decision Date2020-04-29
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Equinoxe® Stemless Humeral Components is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2020-04-29 under 510(k) number K192097. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech® Equinoxe® Stemless Humeral Components?

Exactech® Equinoxe® Stemless Humeral Components is a medical device that received FDA 510(k) clearance on 2020-04-29. The listed applicant is Exactech, Inc.. The 510(k) number is K192097.

When did Exactech® Equinoxe® Stemless Humeral Components receive FDA 510(k) clearance?

Exactech® Equinoxe® Stemless Humeral Components received FDA 510(k) clearance on 2020-04-29, under 510(k) number K192097.

Who is the listed applicant for Exactech® Equinoxe® Stemless Humeral Components?

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

What is the FDA product code for Exactech® Equinoxe® Stemless Humeral Components?

The FDA product code for Exactech® Equinoxe® Stemless Humeral Components is PKC.

Other records listing Exactech, Inc. 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.

K260583Equinoxe® Shoulder SystemK250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsK243448Equinoxe® Shoulder SystemK243275Equinoxe® Scapula Fracture SystemK243839Alteon® HA Femoral StemsK240393Exactech® TRULIANT® Knee System

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Related Devices (Code: PKC)

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.

K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UCK241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K221758SMR Stemless AnatomicLima Corporate S.P.A.

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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