FDA 510(k)

H-Max S stem

K-Number: K160011 · 2016-08-22

Decision Date2016-08-22

Product CodeMEH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

H-Max S stem is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2016-08-22 under approval number K160011. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H-Max S stem?

H-Max S stem is a medical device that received FDA 510(k) clearance on 2016-08-22. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K160011.

When was H-Max S stem approved by the FDA?

H-Max S stem received FDA 510(k) clearance on 2016-08-22, under approval number K160011.

What company makes H-Max S stem?

H-Max S stem is manufactured by Lima Corporate S.P.A..

What is the FDA product code for H-Max S stem?

The FDA product code for H-Max S stem is MEH.

Other Devices by Lima Corporate S.P.A.

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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.