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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 a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2018-08-23 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K173890.

When was GMK Sphere - Kinematic Alignment approved by the FDA?

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

What company makes GMK Sphere - Kinematic Alignment?

GMK Sphere - Kinematic Alignment is manufactured by Medacta International S.A..

What is the FDA product code for GMK Sphere - Kinematic Alignment?

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

Related Clinical Trials

NCT07533188 Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert Types RECRUITING NCT06158646 Mechanically or Kinematically Aligned Total Knee Prosthesis RECRUITING

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Related Devices (Code: 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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