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FDA 510(k)

Medacta Anatomic Shoulder Prosthesis

K-Number: K170910 · 2017-08-16

ApplicantMedacta International S.A.
Decision Date2017-08-16
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medacta Anatomic Shoulder Prosthesis is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-08-16 under approval number K170910. 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 Medacta Anatomic Shoulder Prosthesis?

Medacta Anatomic Shoulder Prosthesis is a medical device that received FDA 510(k) clearance on 2017-08-16. It is manufactured by Medacta International S.A.. The 510(k) number is K170910.

When was Medacta Anatomic Shoulder Prosthesis approved by the FDA?

Medacta Anatomic Shoulder Prosthesis received FDA 510(k) clearance on 2017-08-16, under approval number K170910.

What company makes Medacta Anatomic Shoulder Prosthesis?

Medacta Anatomic Shoulder Prosthesis is manufactured by Medacta International S.A..

What is the FDA product code for Medacta Anatomic Shoulder Prosthesis?

The FDA product code for Medacta Anatomic Shoulder Prosthesis is KWS.

Related Clinical Trials

NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING NCT05500066 Tornier HRS (Humeral Reconstruction System) Study (REVIVE) ENROLLING_BY_INVITATION

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

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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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