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FDA 510(k)

Materialise PKA Guide System

K-Number: K172650 · 2017-11-20

ApplicantMaterialise NV
Decision Date2017-11-20
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Materialise PKA 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 2017-11-20 under 510(k) number K172650. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Materialise PKA Guide System?

Materialise PKA Guide System is a medical device that received FDA 510(k) clearance on 2017-11-20. The listed applicant is Materialise NV. The 510(k) number is K172650.

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

Materialise PKA Guide System received FDA 510(k) clearance on 2017-11-20, under 510(k) number K172650.

Who is the listed applicant for Materialise PKA 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 PKA Guide System?

The FDA product code for Materialise PKA Guide System is HSX.

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: HSX)

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.

K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, 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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