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FDA 510(k)

Renovis A200 PS Knee System as part of the Renovis A200 Knee System

K-Number: K190122 · 2019-06-20

ApplicantRenovis Surgical Technologies
Decision Date2019-06-20
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Renovis A200 PS Knee System as part of the Renovis A200 Knee System is a medical device manufactured by Renovis Surgical Technologies. It received FDA 510(k) clearance on 2019-06-20 under approval number K190122. 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 Renovis A200 PS Knee System as part of the Renovis A200 Knee System?

Renovis A200 PS Knee System as part of the Renovis A200 Knee System is a medical device that received FDA 510(k) clearance on 2019-06-20. It is manufactured by Renovis Surgical Technologies. The 510(k) number is K190122.

When was Renovis A200 PS Knee System as part of the Renovis A200 Knee System approved by the FDA?

Renovis A200 PS Knee System as part of the Renovis A200 Knee System received FDA 510(k) clearance on 2019-06-20, under approval number K190122.

What company makes Renovis A200 PS Knee System as part of the Renovis A200 Knee System?

Renovis A200 PS Knee System as part of the Renovis A200 Knee System is manufactured by Renovis Surgical Technologies.

What is the FDA product code for Renovis A200 PS Knee System as part of the Renovis A200 Knee System?

The FDA product code for Renovis A200 PS Knee System as part of the Renovis A200 Knee System is JWH.

Other Devices by Renovis Surgical Technologies

K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System K171543Renovis Surgical Hip Replacement System K170888Renovis S141 Lumbar Interbody Fusion System K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System K181655Renovis S180 Lateral Lumbar Interbody Fusion System

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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