Full Wedge Lateralized and Augmented Baseplates
K-Number: K240278 · 2024-05-15
ApplicantFx Shoulder USA, Inc.
Decision Date2024-05-15
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Full Wedge Lateralized and Augmented Baseplates is a medical device manufactured by Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2024-05-15 under approval number K240278. 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 Full Wedge Lateralized and Augmented Baseplates?
Full Wedge Lateralized and Augmented Baseplates is a medical device that received FDA 510(k) clearance on 2024-05-15. It is manufactured by Fx Shoulder USA, Inc.. The 510(k) number is K240278.
When was Full Wedge Lateralized and Augmented Baseplates approved by the FDA?
Full Wedge Lateralized and Augmented Baseplates received FDA 510(k) clearance on 2024-05-15, under approval number K240278.
What company makes Full Wedge Lateralized and Augmented Baseplates?
Full Wedge Lateralized and Augmented Baseplates is manufactured by Fx Shoulder USA, Inc..
What is the FDA product code for Full Wedge Lateralized and Augmented Baseplates?
The FDA product code for Full Wedge Lateralized and Augmented Baseplates is PHX.
Other Devices by Fx Shoulder USA, Inc.
Related Devices (Code: PHX)
K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.
K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation
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.