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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 the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2017-06-01 under 510(k) 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. The listed applicant is Zimmer GmbH. The 510(k) number is K170711.

When did ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System receive FDA 510(k) clearance?

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

Who is the listed applicant for ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Zimmer GmbH 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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