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FDA 510(k)

Exactech Equinoxe Small Reverse Shoulder System

K-Number: K180632 · 2018-07-25

ApplicantExactech, Inc.
Decision Date2018-07-25
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Equinoxe Small Reverse Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2018-07-25 under 510(k) number K180632. 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 Small Reverse Shoulder System?

Exactech Equinoxe Small Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2018-07-25. The listed applicant is Exactech, Inc.. The 510(k) number is K180632.

When did Exactech Equinoxe Small Reverse Shoulder System receive FDA 510(k) clearance?

Exactech Equinoxe Small Reverse Shoulder System received FDA 510(k) clearance on 2018-07-25, under 510(k) number K180632.

Who is the listed applicant for Exactech Equinoxe Small Reverse Shoulder System?

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 Small Reverse Shoulder System?

The FDA product code for Exactech Equinoxe Small Reverse Shoulder System is PHX.

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: 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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