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FDA 510(k)

PRIMA Humeral System and SMR Glenosphere Ø42

K-Number: K212800 · 2022-02-25

ApplicantLima Corporate S.P.A.
Decision Date2022-02-25
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRIMA Humeral System and SMR Glenosphere Ø42 is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2022-02-25 under approval number K212800. 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 PRIMA Humeral System and SMR Glenosphere Ø42?

PRIMA Humeral System and SMR Glenosphere Ø42 is a medical device that received FDA 510(k) clearance on 2022-02-25. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K212800.

When was PRIMA Humeral System and SMR Glenosphere Ø42 approved by the FDA?

PRIMA Humeral System and SMR Glenosphere Ø42 received FDA 510(k) clearance on 2022-02-25, under approval number K212800.

What company makes PRIMA Humeral System and SMR Glenosphere Ø42?

PRIMA Humeral System and SMR Glenosphere Ø42 is manufactured by Lima Corporate S.P.A..

What is the FDA product code for PRIMA Humeral System and SMR Glenosphere Ø42?

The FDA product code for PRIMA Humeral System and SMR Glenosphere Ø42 is PHX.

Related Clinical Trials

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Other Devices by Lima Corporate S.P.A.

K160011H-Max S stem K161476SMR Shoulder System K153722SMR 3-Pegs Glenoids K170473C2 femoral stem K163397SMR Hybrid Glenoid System K161120SMR TT Metal Back Glenoid, Bone Graft instruments

View all 41 devices →

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.

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