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FDA 510(k)

Humeris Shoulder

K-Number: K163669 · 2017-05-17

ApplicantFx Solutions
Decision Date2017-05-17
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Humeris Shoulder is the device name listed in this FDA 510(k) record. The listed applicant is Fx Solutions. It received FDA 510(k) clearance on 2017-05-17 under 510(k) number K163669. 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 Humeris Shoulder?

Humeris Shoulder is a medical device that received FDA 510(k) clearance on 2017-05-17. The listed applicant is Fx Solutions. The 510(k) number is K163669.

When did Humeris Shoulder receive FDA 510(k) clearance?

Humeris Shoulder received FDA 510(k) clearance on 2017-05-17, under 510(k) number K163669.

Who is the listed applicant for Humeris Shoulder?

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

What is the FDA product code for Humeris Shoulder?

The FDA product code for Humeris Shoulder is PHX.

Other records listing Fx Solutions 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.

K162455Humelock Reversed Shoulder

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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