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FDA 510(k)

GMK Sphere - Kinematic Alignment

K-Number: K173890 · 2018-08-23

ApplicantMedacta International S.A.
Decision Date2018-08-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK Sphere - Kinematic Alignment 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 2018-08-23 under 510(k) number K173890. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GMK Sphere - Kinematic Alignment?

GMK Sphere - Kinematic Alignment is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is Medacta International S.A.. The 510(k) number is K173890.

When did GMK Sphere - Kinematic Alignment receive FDA 510(k) clearance?

GMK Sphere - Kinematic Alignment received FDA 510(k) clearance on 2018-08-23, under 510(k) number K173890.

Who is the listed applicant for GMK Sphere - Kinematic Alignment?

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 GMK Sphere - Kinematic Alignment?

The FDA product code for GMK Sphere - Kinematic Alignment is JWH.

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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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