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FDA 510(k)

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System

K-Number: K170711 · 2017-06-01

ApplicantZimmer GmbH
Decision Date2017-06-01
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2017-06-01 under approval number K170711. 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 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System?

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System is a medical device that received FDA 510(k) clearance on 2017-06-01. It is manufactured by Zimmer GmbH. The 510(k) number is K170711.

When was ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System approved by the FDA?

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System received FDA 510(k) clearance on 2017-06-01, under approval number K170711.

What company makes ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System?

ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System is manufactured by Zimmer GmbH.

What is the FDA product code for ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System?

The FDA product code for ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined 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) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

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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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