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FDA 510(k)

SMR Hybrid Glenoid System

K-Number: K163397 · 2017-06-29

Decision Date2017-06-29
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 2017-06-29 under approval number K163397. 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 2017-06-29. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K163397.

When was SMR Hybrid Glenoid System approved by the FDA?

SMR Hybrid Glenoid System received FDA 510(k) clearance on 2017-06-29, under approval number K163397.

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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Official Source

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