FDA 510(k)

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Numéro K : K212569 · 2022-01-12

Date de décision2022-01-12

Code produitQHE

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2022-01-12 under 510(k) number K212569. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is a medical device that received FDA 510(k) clearance on 2022-01-12. The listed applicant is Materialise NV. The 510(k) number is K212569.

When did Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner receive FDA 510(k) clearance?

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner received FDA 510(k) clearance on 2022-01-12, under 510(k) number K212569.

Who is the listed applicant for Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

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 Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

The FDA product code for Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is QHE.

Essais cliniques associés

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Autres dossiers indiquant Materialise NV en tant que demandeur

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Dispositifs connexes (Code : QHE)

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.K243509Archer PSI System3D-Side K241470CORE Shoulder SystemLinkBio Corp.

Source officielle

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