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FDA 510(k)

Materialise Glenoid Positioning System

K-Number: K172054 · 2017-11-03

ApplicantMaterialise NV
Decision Date2017-11-03
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Materialise Glenoid Positioning System is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2017-11-03 under approval number K172054. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Materialise Glenoid Positioning System?

Materialise Glenoid Positioning System is a medical device that received FDA 510(k) clearance on 2017-11-03. It is manufactured by Materialise NV. The 510(k) number is K172054.

When was Materialise Glenoid Positioning System approved by the FDA?

Materialise Glenoid Positioning System received FDA 510(k) clearance on 2017-11-03, under approval number K172054.

What company makes Materialise Glenoid Positioning System?

Materialise Glenoid Positioning System is manufactured by Materialise NV.

What is the FDA product code for Materialise Glenoid Positioning System?

The FDA product code for Materialise Glenoid Positioning System is KWS.

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Other Devices by Materialise NV

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Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

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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