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FDA 510(k)

MUTARS Proximal Femur Replacement System

K-Number: K181778 · 2019-03-25

Decision Date2019-03-25
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MUTARS Proximal Femur Replacement System is a medical device manufactured by Implantcast GmbH. It received FDA 510(k) clearance on 2019-03-25 under approval number K181778. 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 MUTARS Proximal Femur Replacement System?

MUTARS Proximal Femur Replacement System is a medical device that received FDA 510(k) clearance on 2019-03-25. It is manufactured by Implantcast GmbH. The 510(k) number is K181778.

When was MUTARS Proximal Femur Replacement System approved by the FDA?

MUTARS Proximal Femur Replacement System received FDA 510(k) clearance on 2019-03-25, under approval number K181778.

What company makes MUTARS Proximal Femur Replacement System?

MUTARS Proximal Femur Replacement System is manufactured by Implantcast GmbH.

What is the FDA product code for MUTARS Proximal Femur Replacement System?

The FDA product code for MUTARS Proximal Femur Replacement System is MEH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.