Singapore HSA registration DE0505510
Zimmer Signature ONE System
Singapore·CLASS B·Zimmer CAS·Registered February 26, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0505510
- Registration Date
- February 26, 2021
- Retention Due Date
- February 25, 2026
Product description
The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System. The Signature™ ONE Guides and Bone Models are intended for single use only.
Product Owner
- Name
- Zimmer CAS
- Short Name
- Zimmer CAS
- Address
- 75 Queen Street, Suite 3300, Montreal, Quebec, H3C 2N6, CANADA
Registrant
- Name
- ZIMMER PTE. LTD.
- Address
- 401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Importer
- Name
- ZIMMER PTE. LTD.
- Address
- 401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Model information
- Model Name(s)
- Comprehensive® Total Shoulder Guide and Bone Model Left (Pin distance: 23-30mm; Bridge ht: 0-9mm; Inferior brushing ht: 9-12mm) Comprehensive® Total Shoulder Guide and Bone Model Right (Pin distance: 23-30mm; Bridge ht: 0-9mm; Inferior brushing ht: 9-12mm) Comprehensive® Reverse Shoulder Mini Guide and Bone Model Left (Pin distance: 23-30mm; Bridge ht: 0-9mm; Inferior brushing ht: 9-12mm) Comprehensive® Reverse Shoulder Mini Guide and Bone Model Right (Pin distance: 23-30mm; Bridge ht: 0-9mm; Inferior brushing ht: 9-12mm) Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left (Pin distance: 20-30mm; Bridge ht: 0-9mm; Inferior brushing ht: 9-12mm) Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Right (Pin distance: 20-30mm; Bridge ht: 0-9mm; Inferior brushing ht: 9-12mm) Shoulder Bone Model 3.2mm Pin Shoulder Bone Model 2.5mm Pin Signature ONE Software Package
- Model Identifier(s)
- 20-8090-002-01 (Pin distance, bridge ht, Inferior brushing ht) 20-8090-002-02 (Pin distance, bridge ht, Inferior brushing ht) 20-8090-003-01 (Pin distance, bridge ht, Inferior brushing ht) 20-8090-003-02 (Pin distance, bridge ht, Inferior brushing ht) 20-8090-004-01 (Pin distance, bridge ht, Inferior brushing ht) 20-8090-004-02 (Pin distance, bridge ht, Inferior brushing ht) 20-8090-005-00 20-8090-006-00 302.4018
About this record
Access comprehensive regulatory information for Zimmer Signature ONE System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505510 and owned by Zimmer CAS. The device was registered on February 26, 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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