Lateralized and Augmented Baseplates
K-Number: K210790 · 2021-08-25
ApplicantFx Shoulder USA, Inc.
Decision Date2021-08-25
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Lateralized and Augmented Baseplates is a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2021-08-25 under approval number K210790. 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 Lateralized and Augmented Baseplates?
Lateralized and Augmented Baseplates is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K210790.
When was Lateralized and Augmented Baseplates approved by the FDA?
Lateralized and Augmented Baseplates received FDA 510(k) clearance on 2021-08-25, under approval number K210790.
What company makes Lateralized and Augmented Baseplates?
Lateralized and Augmented Baseplates is manufactured by Fx Shoulder USA, Inc..
What is the FDA product code for Lateralized and Augmented Baseplates?
The FDA product code for Lateralized and Augmented Baseplates 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.