FX V135 Shoulder Prosthesis
K-Number: K213117 · 2022-06-07
ApplicantFx Shoulder USA, Inc.
Decision Date2022-06-07
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FX V135 Shoulder Prosthesis is a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2022-06-07 under approval number K213117. 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 FX V135 Shoulder Prosthesis?
FX V135 Shoulder Prosthesis is a medical device that received FDA 510(k) clearance on 2022-06-07. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K213117.
When was FX V135 Shoulder Prosthesis approved by the FDA?
FX V135 Shoulder Prosthesis received FDA 510(k) clearance on 2022-06-07, under approval number K213117.
What company makes FX V135 Shoulder Prosthesis?
FX V135 Shoulder Prosthesis is manufactured by Fx Shoulder USA, Inc..
What is the FDA product code for FX V135 Shoulder Prosthesis?
The FDA product code for FX V135 Shoulder Prosthesis is PHX.
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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.