KWT

Product Code: KWT


Products Classified as KWT

4578Prosthesis, Shoulder, Non-constrained, Metal/polymer CementedShoulder Joint Metal/polymer Non-constrained Cemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4578Prosthesis, Shoulder, Non-constrained, Metal/polymer CementedShoulder Joint Metal/polymer Non-constrained Cemented Prosthesis.

FDA Consensus Standards

Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [34059]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [37410]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [37411]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [37435]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [35610]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [37433]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [37816]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [33508]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [37831]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [32210]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [37814]21 CFR §888.3650 🔎
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented [38290]21 CFR §888.3650 🔎

Pre-market Notifications for KWT

K222482AGILON XO Shoulder SystemImplantcast, GmbH
K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG
K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations Inc
K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst OrthoScience, Inc.
K191698TiN Coated Humeral HeadFX Shoulder USA, Inc.
K190595Signature ONE SystemOrthosoft Inc. (d/b/a Zimmer CAS)
K190521Aequalis Ascend Flex Shoulder SystemTornier SAS
K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst OrthoScience, Inc.
K181287Catalyst CSR Shoulder SystemCatalyst OrthoScience, Inc.
K173812Catalyst CSR 3 Peg GlenoidsCatalyst OrthoScience, Inc
K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech Inc
K161476SMR Shoulder SystemLimacorporate S.p.A.
K152825Catalyst CSR Shoulder SystemCATALYST ORTHOSCIENCE LLC
K150730Zimmer PSI Shoulder SystemZIMMER
K143659Equinoxe Mega ProsthesisEXACTECH, INC.

Global Unique Device Identification Database

00814193025562Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00814193025555Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00814193025548Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00814193025531Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00814193025470Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00814193025463Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00814193025456Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00814193025449Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00880304993310Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00880304993297Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00880304992818Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00880304992801Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00880304992771Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
00880304850392PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
00880304850347PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Maude Adverse Events

EQUINOXEEXACTECH, INC.2020-03-27
EQUINOXEEXACTECH, INC.2020-03-27
EQUINOXEEXACTECH, INC.2020-03-27
EQUINOXEEXACTECH, INC.2020-03-27
EQUINOXEEXACTECH, INC.2020-03-23
EQUINOXEEXACTECH, INC.2020-03-20
EQUINOXEEXACTECH, INC.2020-03-20
EQUINOXEEXACTECH, INC.2020-03-20
HUMELOCK IIFX SOLUTIONS2020-03-20
EQUINOXEEXACTECH, INC.2020-03-17
EQUINOXEEXACTECH, INC.2020-03-17
HUMELOCK IIFX SOLUTIONS2020-03-16
HUMELOCK IIFX SOLUTIONS2020-03-16
SMR HUMERAL HEAD ?50 MMLIMACORPORATE SPA2020-03-13
ARROWFH INDUSTRIE2020-03-11
EQUINOXEEXACTECH, INC.2020-03-09
EQUINOXEEXACTECH, INC.2020-03-04
EQUINOXEEXACTECH, INC.2020-02-28
EQUINOXEEXACTECH, INC.2020-02-28
EQUINOXEEXACTECH, INC.2020-02-28
EQUINOXEEXACTECH, INC.2020-02-28
EQUINOXEEXACTECH, INC.2020-02-28
EQUINOXEEXACTECH, INC.2020-02-26
EQUINOXEEXACTECH, INC.2020-02-26
EQUINOXEEXACTECH, INC.2020-02-26
ARROWFH INDUSTRIE2020-02-26
TM REVERSE BASE PLATEZIMMER BIOMET, INC.2020-02-25
EQUINOXEEXACTECH, INC.2020-02-25
ARROWFH INDUSTRIE2020-02-24
EQUINOXEEXACTECH, INC.2020-02-20
ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-30ZIMMER GMBH2020-02-20
GLENOSPHERE 36 MM DIAMETERZIMMER BIOMET, INC.2020-02-19
EQUINOXEEXACTECH, INC.2020-02-17
UNKNOWN BIO-MODULAR HEADZIMMER BIOMET, INC.2020-02-17
EQUINOXEEXACTECH, INC.2020-02-14
INTERSPACEEXACTECH, INC.2020-02-14
EQUINOXEEXACTECH, INC.2020-02-11
EQUINOXEEXACTECH, INC.2020-02-10
EQUINOXEEXACTECH, INC.2020-02-07
ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42ZIMMER GMBH2020-02-05
EQUINOXEEXACTECH, INC.2020-02-04
HUMELOCK IIFX SOLUTIONS2020-01-31
POLY LINER PLUS 3 MM OFFSET 40 MM DIAMETERZIMMER BIOMET, INC.2020-01-23
ERGOEXACTECH, INC.2020-01-23
EQUINOXEEXACTECH, INC.2020-01-22
SMR -REVERSE RESECTION JIG DPALIMACORPORATE S.P.A.2020-01-21
EQUINOXEEXACTECH, INC.2020-01-21
EQUINOXEEXACTECH, INC.2020-01-21
EQUINOXEEXACTECH, INC.2020-01-21
EQUINOXEEXACTECH, INC.2020-01-16
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