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FDA 510(k)

SMR Hybrid Glenoid System

K-Number: K231099 · 2023-12-21

ApplicantLima Corporate S.P.A.
Decision Date2023-12-21
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR Hybrid Glenoid System is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2023-12-21 under approval number K231099. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMR Hybrid Glenoid System?

SMR Hybrid Glenoid System is a medical device that received FDA 510(k) clearance on 2023-12-21. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K231099.

When was SMR Hybrid Glenoid System approved by the FDA?

SMR Hybrid Glenoid System received FDA 510(k) clearance on 2023-12-21, under approval number K231099.

What company makes SMR Hybrid Glenoid System?

SMR Hybrid Glenoid System is manufactured by Lima Corporate S.P.A..

What is the FDA product code for SMR Hybrid Glenoid System?

The FDA product code for SMR Hybrid Glenoid System is MBF.

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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

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Related Devices (Code: MBF)

K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie K173824Humeral Short Stem SystemShoulder Innovations, Inc. K191963SMR Finned Short StemsLima Corporate S.P.A. K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.

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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