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FDA 510(k)

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays

K-Number: K223833 · 2023-09-14

ApplicantExactech, Inc.
Decision Date2023-09-14
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K223833. 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 Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays?

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Exactech, Inc.. The 510(k) number is K223833.

When did Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays receive FDA 510(k) clearance?

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays received FDA 510(k) clearance on 2023-09-14, under 510(k) number K223833.

Who is the listed applicant for Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays?

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® Reverse Humeral Liners and Humeral Adapter Trays?

The FDA product code for Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays is PHX.

Other records listing Exactech, Inc. as applicant

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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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