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Zimmer Trabecular Metal Total Ankle - HSA Registration DE0505853

Access comprehensive regulatory information for Zimmer Trabecular Metal Total Ankle in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505853 and owned by Zimmer, Inc.. The device was registered on June 09, 2021.

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
DE0505853
Zimmer Trabecular Metal Total Ankle
HSA Registration Number: DE0505853
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Product Description

Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint. The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: โ€ข Rheumatoid arthritis. โ€ข Post-traumatic arthritis. โ€ข Degenerative arthritis. This device is intended for cemented or uncemented use.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0505853
Registration Date
June 09, 2021
Retention Due Date
June 08, 2025
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)
Zimmer Trabecular Metal Total Ankle Talar Provisional Size 1 Left Zimmer Trabecular Metal Total Ankle Talar Provisional Size 2 Left Zimmer Trabecular Metal Total Ankle Talar Provisional Size 3 Left Zimmer Trabecular Metal Total Ankle Talar Provisional Size 4 Left Zimmer Trabecular Metal Total Ankle Talar Provisional Size 5 Left Zimmer Trabecular Metal Total Ankle Talar Provisional Size 6 Left Zimmer Trabecular Metal Total Ankle Talar Provisional Size 1 Right Zimmer Trabecular Metal Total Ankle Talar Provisional Size 2 Right Zimmer Trabecular Metal Total Ankle Talar Provisional Size 3 Right Zimmer Trabecular Metal Total Ankle Talar Provisional Size 4 Right Zimmer Trabecular Metal Total Ankle Talar Provisional Size 5 Right Zimmer Trabecular Metal Total Ankle Talar Provisional Size 6 Right Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 1 Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 1 Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 1 Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 2 Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 2 Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 2 Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 3 Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 3 Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 3 Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 4 Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 4 Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 4 Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 5 Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 5 Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 5 Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 6 Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 6 Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Provisional Size 6 Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Calcaneus Pin Zimmer Trabecular Metal Total Ankle Kirschner Wire; Style 6; 1.6 mm (.062 inch) Diameter Zimmer Trabecular Metal Total Ankle Self Drilling Pin; 4 mm Diameter; 150 mm Length; 40 mm Thread Length Zimmer Trabecular Metal Total Ankle Self Drilling Pin; 5 mm Diameter; 200 mm Length; 80 mm Thread Length Zimmer Trabecular Metal Total Ankle Rail Hole Drill 5 mm Diameter Zimmer Trabecular Metal Total Ankle Pre-Cut Guide Drill 4 mm Diameter Zimmer Trabecular Metal Total Ankle Revision Protective Sleeve Zimmer Trabecular Metal Total Ankle Bur Zimmer Trabecular Metal Total Ankle Alternate Bur Zimmer Trabecular Metal Total Ankle Burr Guard A Zimmer Trabecular Metal Total Ankle Drill Bur Adapter Zimmer Trabecular Metal Total Ankle Burr Guard B Zimmer Trabecular Metal Total Ankle Burr Guard C Zimmer Trabecular Metal Total Ankle Talar Component, Size 1, Left Zimmer Trabecular Metal Total Ankle Talar Component, Size 2, Left Zimmer Trabecular Metal Total Ankle Talar Component, Size 3, Left Zimmer Trabecular Metal Total Ankle Talar Component, Size 4, Left Zimmer Trabecular Metal Total Ankle Talar Component, Size 5, Left Zimmer Trabecular Metal Total Ankle Talar Component, Size 6, Left Zimmer Trabecular Metal Total Ankle Talar Component, Size 1, Right Zimmer Trabecular Metal Total Ankle Talar Component, Size 2, Right Zimmer Trabecular Metal Total Ankle Talar Component, Size 3, Right Zimmer Trabecular Metal Total Ankle Talar Component, Size 4, Right Zimmer Trabecular Metal Total Ankle Talar Component, Size 5, Right Zimmer Trabecular Metal Total Ankle Talar Component, Size 6, Right Zimmer Trabecular Metal Total Ankle Tibial Base Component, Size 1 Zimmer Trabecular Metal Total Ankle Tibial Base Component, Size 2 Zimmer Trabecular Metal Total Ankle Tibial Base Component, Size 3 Zimmer Trabecular Metal Total Ankle Tibial Base Component, Size 4 Zimmer Trabecular Metal Total Ankle Tibial Base Component, Size 5 Zimmer Trabecular Metal Total Ankle Tibial Base Component, Size 6 Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 1, Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 1, Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 1, Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 2, Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 2, Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 2, Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 3, Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 3, Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 3, Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 4, Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 4, Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 4, Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 5, Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 5, Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 5, Plus (+) 4 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 6, Plus (+) 0 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 6, Plus (+) 2 mm Thickness Zimmer Trabecular Metal Total Ankle Tibial Insert Component, Size 6, Plus (+) 4 mm Thickness
Model Identifier(s)
00-4501-011-00 00-4501-012-00 00-4501-013-00 00-4501-014-00 00-4501-015-00 00-4501-016-00 00-4501-021-00 00-4501-022-00 00-4501-023-00 00-4501-024-00 00-4501-025-00 00-4501-026-00 00-4501-031-00 00-4501-031-02 00-4501-031-04 00-4501-032-00 00-4501-032-02 00-4501-032-04 00-4501-033-00 00-4501-033-02 00-4501-033-04 00-4501-034-00 00-4501-034-02 00-4501-034-04 00-4501-035-00 00-4501-035-02 00-4501-035-04 00-4501-036-00 00-4501-036-02 00-4501-036-04 00-4501-040-00 00-4501-040-01 00-4501-040-04 00-4501-040-05 00-4501-058-00 00-4501-059-00 00-4501-067-03 00-4501-076-00 00-4501-076-01 00-4501-077-00 00-4501-078-01 00-4501-081-00 00-4501-083-00 00-8300-011-00 00-8300-012-00 00-8300-013-00 00-8300-014-00 00-8300-015-00 00-8300-016-00 00-8300-021-00 00-8300-022-00 00-8300-023-00 00-8300-024-00 00-8300-025-00 00-8300-026-00 00-8300-041-00 00-8300-042-00 00-8300-043-00 00-8300-044-00 00-8300-045-00 00-8300-046-00 00-8300-051-00 00-8300-051-02 00-8300-051-04 00-8300-052-00 00-8300-052-02 00-8300-052-04 00-8300-053-00 00-8300-053-02 00-8300-053-04 00-8300-054-00 00-8300-054-02 00-8300-054-04 00-8300-055-00 00-8300-055-02 00-8300-055-04 00-8300-056-00 00-8300-056-02 00-8300-056-04