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FDA 510(k)

CKS Plus Knee System

K-Number: K163167 · 2017-08-09

ApplicantConsensus Orthopedics, Inc.
Decision Date2017-08-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CKS Plus 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 2017-08-09 under 510(k) number K163167. 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 CKS Plus Knee System?

CKS Plus Knee System is a medical device that received FDA 510(k) clearance on 2017-08-09. The listed applicant is Consensus Orthopedics, Inc.. The 510(k) number is K163167.

When did CKS Plus Knee System receive FDA 510(k) clearance?

CKS Plus Knee System received FDA 510(k) clearance on 2017-08-09, under 510(k) number K163167.

Who is the listed applicant for CKS Plus 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 CKS Plus Knee System?

The FDA product code for CKS Plus Knee System is JWH.

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.

K170344Tahoe Uni Knee SystemK160515PS2 Knee System

Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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