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FDA 510(k)

Materialise TKA Guide System

K-Number: K162273 · 2016-11-07

ApplicantMaterialise NV
Decision Date2016-11-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Materialise TKA Guide System is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K162273. 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 Materialise TKA Guide System?

Materialise TKA Guide System is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Materialise NV. The 510(k) number is K162273.

When did Materialise TKA Guide System receive FDA 510(k) clearance?

Materialise TKA Guide System received FDA 510(k) clearance on 2016-11-07, under 510(k) number K162273.

Who is the listed applicant for Materialise TKA Guide System?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Materialise TKA Guide System?

The FDA product code for Materialise TKA Guide System is JWH.

Other records listing Materialise NV 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.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerK251964Mimics Thoracic PlannerK253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsK253793Materialise TKA Guide SystemK251554Materialise TKA Guide SystemK243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

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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.

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 NVK252974EMPOWR KneeEncore 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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