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510(k) K190595

Device
Signature ONE System
Applicant
Orthosoft Inc. (d/b/a Zimmer CAS)
510(k) number
K190595
Product code
KWT  
Decision
Substantially Equivalent (SESE)
Decision date
2019-06-05
Date received
2019-03-07
Regulation
888.3650
Classification name
Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Paul Hardy
Address
75 Queen St. Suite 3300 Montreal CA H3C 2N6 H3C 2N6

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.2025-12-01
K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.2025-10-30
K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH2025-03-10
K241817InSet Total Shoulder SystemShoulder Innovations, Inc.2025-02-11
K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH2024-02-16
K223631Comprehensive Segmental Revision System(SRS)Biomet Orthopedics2023-07-12
K222482AGILON XO Shoulder SystemImplantcast GmbH2022-09-28
K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG2021-06-21
K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.2020-07-16
K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.2019-11-29
K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.2019-09-11
K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.2019-01-11
K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.2018-07-12
K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.2018-03-09
K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.2017-02-27

Legacy Summary#

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FDA Review#

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