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FDA 510(k)

GMK Sphere CR Tibial Inserts

K-Number: K181635 · 2018-08-23

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

Device Summary

GMK Sphere CR Tibial Inserts 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 K181635. 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 CR Tibial Inserts?

GMK Sphere CR Tibial Inserts 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 K181635.

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

GMK Sphere CR Tibial Inserts received FDA 510(k) clearance on 2018-08-23, under 510(k) number K181635.

Who is the listed applicant for GMK Sphere CR Tibial Inserts?

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 CR Tibial Inserts?

The FDA product code for GMK Sphere CR Tibial Inserts is JWH.

Other records listing Medacta International S.A. as applicant

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.

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Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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