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FDA 510(k)

AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared

K-Number: K173794 · 2018-03-14

ApplicantMedacta International S.A.
Decision Date2018-03-14
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2018-03-14 under approval number K173794. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared?

AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared is a medical device that received FDA 510(k) clearance on 2018-03-14. It is manufactured by Medacta International S.A.. The 510(k) number is K173794.

When was AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared approved by the FDA?

AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared received FDA 510(k) clearance on 2018-03-14, under approval number K173794.

What company makes AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared?

AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared is manufactured by Medacta International S.A..

What is the FDA product code for AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared?

The FDA product code for AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared is LZO.

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Related Devices (Code: LZO)

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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.

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