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Zimmer CPT Hip System - HSA Registration DE0018497

Access comprehensive regulatory information for Zimmer CPT Hip System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018497 and owned by Zimmer Inc. The device was registered on August 25, 2016.

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
DE0018497
Zimmer CPT Hip System
HSA Registration Number: DE0018497
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Product Description

The Zimmer CPT® Hip System is indicated for cemented use in: • Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. • Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis. • Patients suffering from disability due to previous fusion. • Patients with previously failed endoprostheses and/or total hip components in the affected extremity. • Patients with acute femoral neck fractures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0018497
Registration Date
August 25, 2016
Retention Due Date
August 24, 2025
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)
VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 22 MM DIAMETER STANDARD +0 MM NECK LENGTH VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 22 MM DIA. -2.0 MM NECK LENGTH VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 22 MM DIA. +3.0 MM NECK LENGTH VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 28 MM DIAMETER -3.5 MM NECK LENGTH VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 28 MM DIAMETER STANDARD +0 MM NECK LENGTH VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPE 28 MM DIAMETER +3.5 MM NECK LENGTH VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 28 MM DIAMETER +7 MM NECK LENGTH VERSYS® HIP SYSTEM PROVISIONAL FEMORAL HEAD 12/14 NECK TAPER 28 MM DIAMETER +10.5 MM NECK LENGTH CPT® HIP SYSTEM CONE PROVISIONAL CPT® HIP SYSTEM CONE PROVISIONAL EXTENDED NECK OFFSET CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 0, 105mm Stem Length, Packaged with Revision Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 0, 105mm Stem Length, Packaged with Revision Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 1, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 1, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 2, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 2, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 2, 180mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extra Extended Offset, Size 2, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 3, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 3, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 3, 180mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extra Extended Offset, Size 3, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 4, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 4, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 4, 200mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 4, 230mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 4, 260mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extra Extended Offset, Size 4, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Standard Offset, Size 5, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extended Offset, Size 5, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extra Extended Offset, Size 5, 130mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Valgus Neck (VN), Size 2, 180mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Valgus Neck (VN), Size 3, 180mm Stem Length, Packaged with Standard Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Extra Small, 85mm Stem Length, Packaged w/ Revision Centralizer CPT Hip System, Femoral Stem, 12/14 Neck Taper, Small, 95mm Stem Length, Packaged w/ Revision Centralizer CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 0 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 1 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 2 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 3 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 4 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL STANDARD OFFSET SIZE 5 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION STEM PROVISIONAL EXTRA SMALL CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION STEM PROVISIONAL SMALL CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 0 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 1 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 2 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 3 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 4 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTENDED OFFSET SIZE 5 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTRA EXTENDED OFFSET SIZE 2 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTRA EXTENDED OFFSET SIZE 3 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTRA EXTENDED OFFSET SIZE 4 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION CONE PROVISIONAL EXTRA EXTENDED OFFSET SIZE 5 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION - REVISION CONE PROVISIONAL VALGUS NECK (VN) SIZE 2 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION - REVISION CONE PROVISIONAL VALGUS NECK (VN) SIZE 3 CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION STEM PROVISIONAL EXTENDED OFFSET SIZE 4 230 MM LENGTH CPT® HIP SYSTEM 12/14 TAPER INSTRUMENTATION STEM PROVISIONAL EXTENDED OFFSET SIZE 4 260 MM LENGTH CPT Hip System Cement Pressurizer, Small CPT Hip System Cement Pressurizer, Medium CPT Hip System Cement Pressurizer, Large CPT Hip System Cement Pressurizer, Small, Quantity - 5 CPT Hip System Cement Pressurizer, Medium, Quantity - 5 CPT Hip System Cement Pressurizer, Large, Quantity - 5 CPT Hip System Centralizer For use w/CPT Femoral Stems CPT Hip System Revision Centralizer For use w/CPT Femoral Stems CPT Hip System Femoral Pressurizer Seal, Large, Blue CPT Hip System Femoral Pressurizer Seal, Small, Natural CPT Hip System Cement Restrictor Seal
Model Identifier(s)
00-7895-022-02 00-7895-022-20 00-7895-022-30 00-7895-028-01 00-7895-028-02 00-7895-028-03 00-7895-028-04 00-7895-028-05 00-8011-101-00 00-8011-101-20 00-8114-000-00 00-8114-000-10 00-8114-001-00 00-8114-001-10 00-8114-002-00 00-8114-002-10 00-8114-002-18 00-8114-002-30 00-8114-003-00 00-8114-003-10 00-8114-003-18 00-8114-003-30 00-8114-004-00 00-8114-004-10 00-8114-004-20 00-8114-004-23 00-8114-004-26 00-8114-004-30 00-8114-005-00 00-8114-005-10 00-8114-005-30 00-8114-012-18 00-8114-013-18 00-8114-040-00 00-8114-050-00 00-8334-015-00 00-8334-015-01 00-8334-015-02 00-8334-015-03 00-8334-015-04 00-8334-015-05 00-8334-015-40 00-8334-015-50 00-8334-020-00 00-8334-020-01 00-8334-020-02 00-8334-020-03 00-8334-020-04 00-8334-020-05 00-8334-025-02 00-8334-025-03 00-8334-025-04 00-8334-025-05 00-8334-026-02 00-8334-026-03 00-8334-070-25 00-8334-070-26 00-8334-084-01 00-8334-084-02 00-8334-084-03 00-8334-084-51 00-8334-084-52 00-8334-084-53 32-8333-055-00 32-8333-056-00 32-8334-010-01 32-8334-010-02 32-8334-012-00