Glenoid Baseplate with Screw
K-Number: K192799 · 2020-02-21
ApplicantFx Shoulder USA, Inc.
Decision Date2020-02-21
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Glenoid Baseplate with Screw is a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2020-02-21 under approval number K192799. 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 Glenoid Baseplate with Screw?
Glenoid Baseplate with Screw is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K192799.
When was Glenoid Baseplate with Screw approved by the FDA?
Glenoid Baseplate with Screw received FDA 510(k) clearance on 2020-02-21, under approval number K192799.
What company makes Glenoid Baseplate with Screw?
Glenoid Baseplate with Screw is manufactured by Fx Shoulder USA, Inc..
What is the FDA product code for Glenoid Baseplate with Screw?
The FDA product code for Glenoid Baseplate with Screw 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.