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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 a medical device manufactured by Consensus Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-10-05 under approval 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. It is manufactured by Consensus Orthopedics, Inc.. The 510(k) number is K170344.

When was Tahoe Uni Knee System approved by the FDA?

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

What company makes Tahoe Uni Knee System?

Tahoe Uni Knee System is manufactured by Consensus Orthopedics, Inc..

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

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

Other Devices by Consensus Orthopedics, Inc.

K160515PS2 Knee System K163167CKS Plus Knee System

Related Devices (Code: HSX)

K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc. K161592Persona Partial Knee SystemBiomet, Inc. K160738ZUK Select Knee SystemSmith & Nephew, Inc. K172650Materialise PKA Guide SystemMaterialise NV K161741GMK UNIMedacta International S.A. K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, 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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