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FDA 510(k)

TiN Coated Humeral Head

K-Number: K191698 · 2020-07-16

ApplicantFx Shoulder USA, Inc.
Decision Date2020-07-16
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TiN Coated Humeral Head is the device name listed in this FDA 510(k) record. The listed applicant is Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K191698. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TiN Coated Humeral Head?

TiN Coated Humeral Head is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K191698.

When did TiN Coated Humeral Head receive FDA 510(k) clearance?

TiN Coated Humeral Head received FDA 510(k) clearance on 2020-07-16, under 510(k) number K191698.

Who is the listed applicant for TiN Coated Humeral Head?

The FDA 510(k) record lists Fx Shoulder USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TiN Coated Humeral Head?

The FDA product code for TiN Coated Humeral Head is KWT.

Other records listing Fx Shoulder USA, Inc. 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.

K240278Full Wedge Lateralized and Augmented BaseplatesK223801FX V135(TM) Shoulder ProsthesisK222936Humeris® 135 Shoulder SystemK213117FX V135 Shoulder ProsthesisK210790Lateralized and Augmented BaseplatesK201391Easytech® Anatomical Shoulder System

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Related Devices (Code: KWT)

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.

K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbHK223631Comprehensive Segmental Revision System(SRS)Biomet Orthopedics

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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