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FDA 510(k)

Exactech Equinoxe Stemless Shoulder

K-Number: K173388 · 2018-03-09

ApplicantExactech, Inc.
Decision Date2018-03-09
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Equinoxe Stemless Shoulder is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2018-03-09 under approval number K173388. 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 Shoulder?

Exactech Equinoxe Stemless Shoulder is a medical device that received FDA 510(k) clearance on 2018-03-09. It is manufactured by Exactech, Inc.. The 510(k) number is K173388.

When was Exactech Equinoxe Stemless Shoulder approved by the FDA?

Exactech Equinoxe Stemless Shoulder received FDA 510(k) clearance on 2018-03-09, under approval number K173388.

What company makes Exactech Equinoxe Stemless Shoulder?

Exactech Equinoxe Stemless Shoulder is manufactured by Exactech, Inc..

What is the FDA product code for Exactech Equinoxe Stemless Shoulder?

The FDA product code for Exactech Equinoxe Stemless Shoulder is PKC.

Related Clinical Trials

NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39081796 Recent Advances in the Design and Application of Shoulder Arthroplasty Implant Systems and Their Impact on Clinical Outcomes: A Comprehensive Review. Orthopedic research and reviews (2024)

Other Devices by Exactech, Inc.

K153649Exactech® Novation® Element Press-fit Femoral Stem K160697Gibralt® Spine System and Gibralt® Occipital Spine System K153595Optetrak Logic Metaphyseal Cones K160484Optetrak Advanced Patella K152217Exactech Vantage Total Ankle System K153776Optetrak One Logic Femoral Components

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Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P. K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.

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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