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FDA 510(k)

GMK Sphere

K-Number: K162035 · 2017-03-06

ApplicantMedacta International S.A.
Decision Date2017-03-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK Sphere 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 2017-03-06 under 510(k) number K162035. 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?

GMK Sphere is a medical device that received FDA 510(k) clearance on 2017-03-06. The listed applicant is Medacta International S.A.. The 510(k) number is K162035.

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

GMK Sphere received FDA 510(k) clearance on 2017-03-06, under 510(k) number K162035.

Who is the listed applicant for GMK Sphere?

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?

The FDA product code for GMK Sphere is JWH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03391323Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes StudyCOMPLETED

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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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