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FDA 510(k)

Tahoe Uni Knee System

K-Number: K170344 · 2017-10-05

ApplicantConsensus Orthopedics, Inc.
Decision Date2017-10-05
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tahoe Uni Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Consensus Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-10-05 under 510(k) number K170344. 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 Tahoe Uni Knee System?

Tahoe Uni Knee System is a medical device that received FDA 510(k) clearance on 2017-10-05. The listed applicant is Consensus Orthopedics, Inc.. The 510(k) number is K170344.

When did Tahoe Uni Knee System receive FDA 510(k) clearance?

Tahoe Uni Knee System received FDA 510(k) clearance on 2017-10-05, under 510(k) number K170344.

Who is the listed applicant for Tahoe Uni Knee System?

The FDA 510(k) record lists Consensus Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tahoe Uni Knee System?

The FDA product code for Tahoe Uni Knee System is HSX.

Other records listing Consensus Orthopedics, Inc. 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.

K163167CKS Plus Knee SystemK160515PS2 Knee System

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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