Humelock Reversed Shoulder
K-Number: K162455 · 2017-01-17
ApplicantFx Solutions
Decision Date2017-01-17
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Humelock Reversed Shoulder is a medical device manufactured by Fx Solutions. It received FDA 510(k) clearance on 2017-01-17 under approval number K162455. 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 Humelock Reversed Shoulder?
Humelock Reversed Shoulder is a medical device that received FDA 510(k) clearance on 2017-01-17. It is manufactured by Fx Solutions. The 510(k) number is K162455.
When was Humelock Reversed Shoulder approved by the FDA?
Humelock Reversed Shoulder received FDA 510(k) clearance on 2017-01-17, under approval number K162455.
What company makes Humelock Reversed Shoulder?
Humelock Reversed Shoulder is manufactured by Fx Solutions.
What is the FDA product code for Humelock Reversed Shoulder?
The FDA product code for Humelock Reversed Shoulder is PHX.
Related Clinical Trials
Other Devices by Fx Solutions
Related Devices (Code: PHX)
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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.