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Zimmer Comprehensive Reverse Shoulder System (Titanium Alloy) - HSA Registration DE0504365

Access comprehensive regulatory information for Zimmer Comprehensive Reverse Shoulder System (Titanium Alloy) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504365 and owned by Zimmer, Inc.. The device was registered on April 13, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0504365
Zimmer Comprehensive Reverse Shoulder System (Titanium Alloy)
HSA Registration Number: DE0504365
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Product Description

Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0504365
Registration Date
April 13, 2020
Retention Due Date
April 12, 2026
Product Owner
Short Name
Zimmer, Inc.
Address
1800 West Center Street, Warsaw, Indiana 46580, UNITED STATES
Registrant
Address
401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Importer
Address
401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Model Information
Model Name(s)
Comprehensive Versa-Dial Reverse Shoulder System Glenosphere Standard Lateral Offset 40mm Diameter Comprehensive Versa-Dial Reverse Shoulder System Glenosphere +3mm Lateral Offset 40mm Diameter Comprehensive Versa-Dial Reverse Shoulder System Glenosphere +6mm Lateral Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +0mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +5mm Thickness +0mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +10mm Thickness +0mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +3mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +5mm Thickness +3mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +10mm Thickness +3mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Standard Thickness +6mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +5mm Thickness +6mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray +10mm Thickness +6mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Vivacit-E Highly Crosslinked Polyethylene Bearing Standard 36mm Diameter Comprehensive Reverse Shoulder System Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter 36mm Diameter Comprehensive Reverse Shoulder System Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 36mm Diameter Comprehensive Reverse Shoulder System Vivacit-E Highly Crosslinked Polyethylene Bearing Standard 40mm Diameter Comprehensive Reverse Shoulder System Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter40mm Diameter Comprehensive Reverse Shoulder System Vivacit-E Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 40mm Diameter
Model Identifier(s)
110030779 110030780 110030781 110031408 110031409 110031410 110031411 110031412 110031413 110031414 110031415 110031416 110031424 110031425 110031426 110031427 110031428 110031429