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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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2018-03-14 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K173794.

When did AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared receive FDA 510(k) clearance?

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

Who is the listed applicant for AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

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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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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