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FDA 510(k)

Integra TITAN Reverse Shoulder System

K-Number: K181999 · 2018-10-12

ApplicantIntegra LifeSciences Corporation
Decision Date2018-10-12
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Integra TITAN Reverse Shoulder System is a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2018-10-12 under approval number K181999. 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 Integra TITAN Reverse Shoulder System?

Integra TITAN Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2018-10-12. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K181999.

When was Integra TITAN Reverse Shoulder System approved by the FDA?

Integra TITAN Reverse Shoulder System received FDA 510(k) clearance on 2018-10-12, under approval number K181999.

What company makes Integra TITAN Reverse Shoulder System?

Integra TITAN Reverse Shoulder System is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for Integra TITAN Reverse Shoulder System?

The FDA product code for Integra TITAN Reverse Shoulder System is PHX.

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Integra LifeSciences Corporation

K160811CRW STEREOTACTIC SYSTEM K161882CUSA Clarity Ultrasonic Surgical Aspirator System K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems K161189Integra TITAN Reverse Shoulder System K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory

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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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