32mm Glenosphere and Humeral Cup
K-Number: K192206 · 2019-10-08
ApplicantFx Shoulder USA, Inc.
Decision Date2019-10-08
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
32mm Glenosphere and Humeral Cup is a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2019-10-08 under approval number K192206. 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 32mm Glenosphere and Humeral Cup?
32mm Glenosphere and Humeral Cup is a medical device that received FDA 510(k) clearance on 2019-10-08. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K192206.
When was 32mm Glenosphere and Humeral Cup approved by the FDA?
32mm Glenosphere and Humeral Cup received FDA 510(k) clearance on 2019-10-08, under approval number K192206.
What company makes 32mm Glenosphere and Humeral Cup?
32mm Glenosphere and Humeral Cup is manufactured by Fx Shoulder USA, Inc..
What is the FDA product code for 32mm Glenosphere and Humeral Cup?
The FDA product code for 32mm Glenosphere and Humeral Cup 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.