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Zimmer Comprehensive Reverse Shoulder System (Cobalt Alloy) - HSA Registration DE0504295

Access comprehensive regulatory information for Zimmer Comprehensive Reverse Shoulder System (Cobalt 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 DE0504295 and owned by Zimmer, Inc.. The device was registered on March 30, 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
DE0504295
Zimmer Comprehensive Reverse Shoulder System (Cobalt Alloy)
HSA Registration Number: DE0504295
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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
DE0504295
Registration Date
March 30, 2020
Retention Due Date
March 29, 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 Versa-Dial Reverse Shoulder System Glenosphere Trial Standard Offset 40 mm Diameter Comprehensive Versa-Dial Reverse Shoulder System Glenosphere Trial +3mm Lateral Offset 40 mm Diameter Comprehensive Versa-Dial Reverse Shoulder System Glenosphere Trial +6mm Lateral Offset 40 mm 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 Prolong Highly Crosslinked Polyethylene Bearing Standard 36mm Diameter Comprehensive Reverse Shoulder System Prolong Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter 36mm Diameter Comprehensive Reverse Shoulder System Prolong Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 36mm Diameter Comprehensive Reverse Shoulder System Prolong Highly Crosslinked Polyethylene Bearing Standard 40mm Diameter Comprehensive Reverse Shoulder System Prolong Highly Crosslinked Polyethylene Bearing +3mm Thickness Diameter40mm Diameter Comprehensive Reverse Shoulder System Prolong Highly Crosslinked Polyethylene Bearing +3mm Retentive Thickness 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 Comprehensive Reverse Shoulder System Mini Humeral Tray Trial Standard Thickness +0mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Trial +5mm Thickness +0mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Trial +10mm Thickness +0mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Trial Standard Thickness +3mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Trial +5mm Thickness +3mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Trial +10mm Thickness +3mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Trial Standard Thickness +6mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Trial +5mm Thickness +6mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Mini Humeral Tray Trial +10mm Thickness +6mm Taper Offset 40mm Diameter Comprehensive Reverse Shoulder System Bearing Trial Standard 36mm Diameter Comprehensive Reverse Shoulder System Bearing Trial +3mm Thickness 36mm Diameter Comprehensive Reverse Shoulder System Bearing Trial +3mm Retentive Thickness 36mm Diameter Comprehensive Reverse Shoulder System Bearing Trial Standard 40mm Diameter Comprehensive Reverse Shoulder System Bearing Trial +3mm Thickness 40mm Diameter Comprehensive Reverse Shoulder System Bearing Trial +3mm Retentive Thickness 40mm Diameter
Model Identifier(s)
110030776 110030777 110030778 110030791 110030792 110030793 110031399 110031400 110031401 110031402 110031403 110031404 110031405 110031406 110031407 110031418 110031419 110031420 110031421 110031422 110031423 110031424 110031425 110031426 110031427 110031428 110031429 110031431 110031432 110031433 110031434 110031435 110031436 110031437 110031438 110031439 110031441 110031442 110031443 110031444 110031445 110031446