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FDA 510(k)

Arthrex Fracture Adapter Hemi Shoulder Prosthesis

K-Number: K181555 · 2018-12-21

ApplicantArthrex, Inc.
Decision Date2018-12-21
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Fracture Adapter Hemi Shoulder Prosthesis is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2018-12-21 under approval number K181555. 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 Arthrex Fracture Adapter Hemi Shoulder Prosthesis?

Arthrex Fracture Adapter Hemi Shoulder Prosthesis is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Arthrex, Inc.. The 510(k) number is K181555.

When was Arthrex Fracture Adapter Hemi Shoulder Prosthesis approved by the FDA?

Arthrex Fracture Adapter Hemi Shoulder Prosthesis received FDA 510(k) clearance on 2018-12-21, under approval number K181555.

What company makes Arthrex Fracture Adapter Hemi Shoulder Prosthesis?

Arthrex Fracture Adapter Hemi Shoulder Prosthesis is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Fracture Adapter Hemi Shoulder Prosthesis?

The FDA product code for Arthrex Fracture Adapter Hemi Shoulder Prosthesis is KWS.

Other Devices by Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161782Arthrex Univers Revers Shoulder Prosthesis System K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters

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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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