HSA · registration DE0016749Zimmer® Distal Radius Plating System (Sterile)
SingaporeOrthopaedicsClass CZimmer Inc
Official record identity
- Registration number
- DE0016749
- Model name
- Provisional Left; Provisional Right; 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; 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
- 00-2328-092-03; 00-2328-093-03; 47-2328-050-03; 47-2328-050-05; 47-2328-051-03; 47-2328-051-05; 47-2328-052-03; 47-2328-052-05; 47-2328-052-08; 47-2328-052-10; 47-2328-052-13; 47-2328-053-03; 47-2328-053-05; 47-2328-053-08; 47-2328-053-10; 47-2328-053-13; 47-2328-054-05; 47-2328-055-05; 47-2328-060-03; 47-2328-061-03; 47-2328-062-03; 47-2328-063-03; 47-2328-070-05; 47-2328-071-05; 47-2328-072-06; 47-2328-073-06; 47-2328-074-05; 47-2328-075-05; 47-2329-010-18; 47-2329-010-24; 47-2329-010-25; 47-2329-011-18; 47-2329-011-24; 47-2329-011-25; 47-2329-012-18; 47-2329-012-24; 47-2329-012-25; 47-2329-013-18; 47-2329-013-24; 47-2329-013-25; 47-2329-014-18; 47-2329-014-24; 47-2329-014-25; 47-2329-015-18; 47-2329-015-24; 47-2329-015-25; 47-2329-016-18; 47-2329-016-24; 47-2329-016-25; 47-2329-017-18; 47-2329-017-24; 47-2329-017-25; 47-2329-018-18; 47-2329-018-24; 47-2329-018-25; 47-2329-019-18; 47-2329-019-24; 47-2329-019-25; 47-2329-020-18; 47-2329-020-24; 47-2329-020-25; 47-2329-022-18; 47-2329-022-24; 47-2329-022-25; 47-2329-024-18; 47-2329-024-24; 47-2329-024-25; 47-2329-026-18; 47-2329-026-24; 47-2329-026-25; 47-2329-028-18; 47-2329-028-24; 47-2329-028-25; 47-2329-030-18; 47-2329-030-24; 47-2329-030-25; 47-2366-030-18; 47-2366-030-24; 47-2366-080-00; 47-2366-085-00
- Registration date
- January 20, 2015
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Zimmer Inc
- Registrant / registration holder
- ZIMMER PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- 1800 West Centre Street, Warsaw IN 46580, United States
- Registrant address
- 401 COMMONWEALTH DRIVE, #06-03, HAW PAR TECHNO CENTRE, Singapore 149598
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.