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FDA 510(k)

SMR TT Metal Back Glenoid, Bone Graft instruments

K-Number: K161120 · 2017-02-21

ApplicantLima Corporate S.P.A.
Decision Date2017-02-21
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR TT Metal Back Glenoid, Bone Graft instruments is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2017-02-21 under approval number K161120. 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 SMR TT Metal Back Glenoid, Bone Graft instruments?

SMR TT Metal Back Glenoid, Bone Graft instruments is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K161120.

When was SMR TT Metal Back Glenoid, Bone Graft instruments approved by the FDA?

SMR TT Metal Back Glenoid, Bone Graft instruments received FDA 510(k) clearance on 2017-02-21, under approval number K161120.

What company makes SMR TT Metal Back Glenoid, Bone Graft instruments?

SMR TT Metal Back Glenoid, Bone Graft instruments is manufactured by Lima Corporate S.P.A..

What is the FDA product code for SMR TT Metal Back Glenoid, Bone Graft instruments?

The FDA product code for SMR TT Metal Back Glenoid, Bone Graft instruments is PHX.

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 K161226Revision Femoral Stem

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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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