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FDA 510(k)

MOTOTM Partial Knee & MOTO PFJ Systems Extension

K-Number: K213071 · 2021-11-16

ApplicantMedacta International S.A.
Decision Date2021-11-16
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOTOTM Partial Knee & MOTO PFJ Systems Extension 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 2021-11-16 under 510(k) number K213071. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOTOTM Partial Knee & MOTO PFJ Systems Extension?

MOTOTM Partial Knee & MOTO PFJ Systems Extension is a medical device that received FDA 510(k) clearance on 2021-11-16. The listed applicant is Medacta International S.A.. The 510(k) number is K213071.

When did MOTOTM Partial Knee & MOTO PFJ Systems Extension receive FDA 510(k) clearance?

MOTOTM Partial Knee & MOTO PFJ Systems Extension received FDA 510(k) clearance on 2021-11-16, under 510(k) number K213071.

Who is the listed applicant for MOTOTM Partial Knee & MOTO PFJ Systems Extension?

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 MOTOTM Partial Knee & MOTO PFJ Systems Extension?

The FDA product code for MOTOTM Partial Knee & MOTO PFJ Systems Extension is HSX.

Other records listing Medacta International S.A. as applicant

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Related Devices (Code: HSX)

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.

K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.

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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