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FDA 510(k)

MyKnee UNI-ST

K-Number: K231037 · 2023-06-09

ApplicantMedacta International S.A.
Decision Date2023-06-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MyKnee UNI-ST 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 2023-06-09 under 510(k) number K231037. 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 MyKnee UNI-ST?

MyKnee UNI-ST is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Medacta International S.A.. The 510(k) number is K231037.

When did MyKnee UNI-ST receive FDA 510(k) clearance?

MyKnee UNI-ST received FDA 510(k) clearance on 2023-06-09, under 510(k) number K231037.

Who is the listed applicant for MyKnee UNI-ST?

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 MyKnee UNI-ST?

The FDA product code for MyKnee UNI-ST is JWH.

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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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