Singapore HSA registration DE0012122
Stryker S.T.A.R Total Ankle Replacement System
Singapore·CLASS C·Stryker GmbH·Registered January 09, 2013Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0012122
- Registration Date
- January 09, 2013
- Change Notification Approval Date
- May 23, 2018
- Retention Due Date
- January 08, 2026
Product description
The Scandinavian Total Ankle Replacement (STAR Ankle) is intended for use as a non-cemented implant to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.
Product Owner
- Name
- Stryker GmbH
- Short Name
- Stryker GmbH
- Address
- Bohnackerweg 1, 2545, Selzach, SWITZERLAND
Registrant
- Address
- 8 JALAN KILANG TIMOR, KEWALRAM HOUSE, #03-04A, SINGAPORE 159305
Importer
- Address
- 8 JALAN KILANG TIMOR, KEWALRAM HOUSE, #03-04A, SINGAPORE 159305
Model information
- Model Name(s)
- Sliding Core, UHMPWe,6m (sterile packaged) Sliding Core, UHMPWe,7mm Slidjng Core, UHMPWe,8mm Sliding Core, UHMPWe,9mm Sliding Core,UHMPWe,10mm Talar Components, Right, XXS Talar Components, Left, XXS Talar Components, Right, XS Talar Components, Left, XS Talar Components, Right, S Talar Components, Left, S Talar Components, Right, Medium Talar Components, Left, Medium Talar Components, Right, Large Talar Components, Left, Large Tibial Components,XS Tibial Components, S Tibial Components, Medium Tibial Components, Large Tibial Components, Xlarge Revision Sliding core STAR Ankle 11mm Revision Sliding core STAR Ankle 12mm Revision Sliding core STAR Ankle 13mm Revision Sliding core STAR Ankle 14mm
- Model Identifier(s)
- 400-140F 400-141F 400-142F 400-143F 400-144F 400-250 400-251 400-252 400-253 400-254 400-255 400-256 400-257 400-258 400-259 400-260 400-261 400-262 400-263 400-264 99-002811F 99-002812F 99-002813F 99-002814F
About this record
Access comprehensive regulatory information for Stryker S.T.A.R Total Ankle Replacement 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 DE0012122 and owned by Stryker GmbH. The device was registered on January 09, 2013.
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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