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FDA 510(k)

CPM Medical Consultants Tibial Revision Knee System

K-Number: K210695 · 2021-08-16

ApplicantCpm Medical Consultants, LLC
Decision Date2021-08-16
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CPM Medical Consultants Tibial Revision Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Cpm Medical Consultants, LLC. It received FDA 510(k) clearance on 2021-08-16 under 510(k) number K210695. 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 CPM Medical Consultants Tibial Revision Knee System?

CPM Medical Consultants Tibial Revision Knee System is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Cpm Medical Consultants, LLC. The 510(k) number is K210695.

When did CPM Medical Consultants Tibial Revision Knee System receive FDA 510(k) clearance?

CPM Medical Consultants Tibial Revision Knee System received FDA 510(k) clearance on 2021-08-16, under 510(k) number K210695.

Who is the listed applicant for CPM Medical Consultants Tibial Revision Knee System?

The FDA 510(k) record lists Cpm Medical Consultants, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPM Medical Consultants Tibial Revision Knee System?

The FDA product code for CPM Medical Consultants Tibial Revision Knee System is JWH.

Related Clinical Trials

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.

NCT02521103Triathlon Tritanium Cone Augments Outcomes StudyACTIVE_NOT_RECRUITINGNCT03153449ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT03153475ATTUNE Revision System in the Revision Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT04389749Continuous Passive Motion Following Fixation of Pelvic and Knee FracturesRECRUITING

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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