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FDA 510(k)

PS2 Knee System

K-Number: K160515 · 2016-12-19

ApplicantConsensus Orthopedics, Inc.
Decision Date2016-12-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PS2 Knee System is a medical device manufactured by Consensus Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-12-19 under approval number K160515. 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 PS2 Knee System?

PS2 Knee System is a medical device that received FDA 510(k) clearance on 2016-12-19. It is manufactured by Consensus Orthopedics, Inc.. The 510(k) number is K160515.

When was PS2 Knee System approved by the FDA?

PS2 Knee System received FDA 510(k) clearance on 2016-12-19, under approval number K160515.

What company makes PS2 Knee System?

PS2 Knee System is manufactured by Consensus Orthopedics, Inc..

What is the FDA product code for PS2 Knee System?

The FDA product code for PS2 Knee System is JWH.

Other Devices by Consensus Orthopedics, Inc.

K170344Tahoe Uni Knee System K163167CKS Plus Knee System

Related Devices (Code: JWH)

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. K162222GENflex2 Total Knee SystemStelkast, 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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