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FDA 510(k)

Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw

K-Number: K162325 · 2017-03-06

ApplicantExactech, Inc.
Decision Date2017-03-06
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2017-03-06 under approval number K162325. 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 Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw?

Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw is a medical device that received FDA 510(k) clearance on 2017-03-06. It is manufactured by Exactech, Inc.. The 510(k) number is K162325.

When was Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw approved by the FDA?

Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw received FDA 510(k) clearance on 2017-03-06, under approval number K162325.

What company makes Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw?

Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw is manufactured by Exactech, Inc..

What is the FDA product code for Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw?

The FDA product code for Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw is PHX.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING NCT07464977 EMG and Delta Function in Standard RTSA vs Lateralization NOT_YET_RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07515092 Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic Residents ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

Other Devices by Exactech, Inc.

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, 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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