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Zimmer® Distal Radius Plating System (Non-Sterile) - HSA Registration DE0016748

Access comprehensive regulatory information for Zimmer® Distal Radius Plating System (Non-Sterile) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016748 and owned by Zimmer Inc. The device was registered on January 20, 2015.

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
DE0016748
Zimmer® Distal Radius Plating System (Non-Sterile)
HSA Registration Number: DE0016748
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Product Description

The Zimmer® Distal Radius Plating System is intended for use in surgical reduction, internal fixation, and stabilization of fractures and osteotomies of the distal radius. Examples of distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures, fractures in osteopenic bone, non-unions and mal-unions.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
HSA Product Code
HSAMDC00107
HS Code
90211000
Registration Information
Registration Number
DE0016748
Registration Date
January 20, 2015
Retention Due Date
January 19, 2026
Product Owner
Short Name
Zimmer
Address
1800 West Centre Street, Warsaw IN 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)
Volar Plate Narrow Left 3 Hole Volar Plate Narrow Left 5 Hole Volar Plate Narrow Right 3 Hole Volar Plate Narrow Right 5 Hole Volar Plate Standard Left 3 Hole Volar Plate Standard Left 5 Hole Volar Plate Standard Left 8 Hole Volar Plate Standard Left 10 Hole Volar Plate Standard Left 13 Hole Volar Plate Standard Right 3 Hole Volar Plate Standard Right 5 Hole Volar Plate Standard Right 8 Hole Volar Plate Standard Right 10 Hole Volar Plate Standard Right 13 Hole Volar Plate Wide Left 5 Hole Volar Plate Wide Right 5 Hole Extra-Articular Plate Narrow Left Extra-Articular Plate Narrow Right Extra-Articular Plate Standard Left Extra-Articular Plate Standard Right Radial Styloid Plate Left Radial Styloid Plate Right Dorsal Radial Column Plate Left Dorsal Radial Column Plate Right Dorsal Ulnar Column Plate Left Dorsal Ulnar Column Plate Right Provisional Left Provisional Right Locking Peg 1.8mm Diameter 10mm Length Locking Screw 2.4mm Diameter 10mm Length Cortical Screw 2.4mm Diameter 10mm Length Locking Peg 1.8mm Diameter 11mm Length Locking Screw 2.4mm Diameter 11mm Length Cortical Screw 2.4mm Diameter 11mm Length Locking Peg 1.8mm Diameter 12mm Length Locking Screw 2.4mm Diameter 12mm Length Cortical Screw 2.4mm Diameter 12mm Length Locking Peg 1.8mm Diameter 13m Length Locking Screw 2.4mm Diameter 13mm Length Cortical Screw 2.4mm Diameter 13mm Length Locking Peg 1.8mm Diameter 14mm Length Locking Screw 2.4mm Diameter 14mm Length Cortical Screw 2.4mm Diameter 14mm Length Locking Peg 1.8mm Diameter 15mm Length Locking Screw 2.4mm Diameter 15mm Length Cortical Screw 2.4mm Diameter 15mm Length Locking Peg 1.8mm Diameter 16mm Length Locking Screw 2.4mm Diameter 16mm Length Cortical Screw 2.4mm Diameter 16mm Length Locking Peg 1.8mm Diameter 17mm Length Locking Screw 2.4mm Diameter 17mm Length Cortical Screw 2.4mm Diameter 17mm Length Locking Peg 1.8mm Diameter 18mm Length Locking Screw 2.4mm Diameter 18mm Length Cortical Screw 2.4mm Diameter 18mm Length Locking Peg 1.8mm Diameter 19mm Length Locking Screw 2.4mm Diameter 19mm Length Cortical Screw 2.4mm Diameter 19m Length Locking Peg 1.8mm Diameter 20mm Length Locking Screw 2.4mm Diameter 20mm Length Cortical Screw 2.4mm Diameter 20mm Length Locking Peg 1.8mm Diameter 22mm Length Locking Screw 2.4mm Diameter 22mm Length Cortical Screw 2.4mm Diameter 22mm Length Locking Peg 1.8mm Diameter 24mm Length Locking Screw 2.4mm Diameter 24mm Length Cortical Screw 2.4mm Diameter 24mm Length Locking Peg 1.8mm Diameter 26mm Length Locking Screw 2.4mm Diameter 26mm Length Cortical Screw 2.4mm Diameter 26mm Length Locking Peg 1.8mm Diameter 28mm Length Locking Screw 2.4mm Diameter 28mm Length Cortical Screw 2.4mm Diameter 28mm Length Locking Peg 1.8mm Diameter 30mm Length Locking Screw 2.4mm Diameter 30mm Length Cortical Screw 2.4mm Diameter 30mm Length Calibrated Drill Bit AO 1.8mm Diameter Calibrated Drill Bit AO 2.4mm Diameter Kirschner Wire 1.25mm Diameter 102mm Length Olive Wire 1.25mm Diameter
Model Identifier(s)
00-2328-050-03 00-2328-050-05 00-2328-051-03 00-2328-051-05 00-2328-052-03 00-2328-052-05 00-2328-052-08 00-2328-052-10 00-2328-052-13 00-2328-053-03 00-2328-053-05 00-2328-053-08 00-2328-053-10 00-2328-053-13 00-2328-054-05 00-2328-055-05 00-2328-060-03 00-2328-061-03 00-2328-062-03 00-2328-063-03 00-2328-070-05 00-2328-071-05 00-2328-072-06 00-2328-073-06 00-2328-074-05 00-2328-075-05 00-2328-092-03 00-2328-093-03 00-2329-010-18 00-2329-010-24 00-2329-010-25 00-2329-011-18 00-2329-011-24 00-2329-011-25 00-2329-012-18 00-2329-012-24 00-2329-012-25 00-2329-013-18 00-2329-013-24 00-2329-013-25 00-2329-014-18 00-2329-014-24 00-2329-014-25 00-2329-015-18 00-2329-015-24 00-2329-015-25 00-2329-016-18 00-2329-016-24 00-2329-016-25 00-2329-017-18 00-2329-017-24 00-2329-017-25 00-2329-018-18 00-2329-018-24 00-2329-018-25 00-2329-019-18 00-2329-019-24 00-2329-019-25 00-2329-020-18 00-2329-020-24 00-2329-020-25 00-2329-022-18 00-2329-022-24 00-2329-022-25 00-2329-024-18 00-2329-024-24 00-2329-024-25 00-2329-026-18 00-2329-026-24 00-2329-026-25 00-2329-028-18 00-2329-028-24 00-2329-028-25 00-2329-030-18 00-2329-030-24 00-2329-030-25 00-2366-030-18 00-2366-030-24 00-2366-080-00 00-2366-085-00