Saudi Arabia SFDA registration ME0000003224SFDAA00472
Sigma® Tibial Insert Rotating Platform STABILIZED
Saudi Arabia·Medical Device·DePuy Orthopaedics, Inc.·Class IIIActiveProduct information
Replacement of knee joint articulation
Product use
Provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Device classification
- Risk Class
- Class III
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000003224SFDAA00472
- Authorization ID
- MDMA-1-2019-1851
- Status
- Active
- Expire Date
- May 26, 2027
Manufacturer
- Manufacturer Name
- DePuy Orthopaedics, Inc.
Model information
- Model ID(s)
- 196192111
Product accessories
[{'tradeName': ' Global ® APG+ Low Profile Central Reamer', 'description': 'Instruments used to implant orthopedics prostheses\n', 'gmdn': 'NA'}, {'tradeName': ' Control ™ Cable Sleeve – Cobalt Chrome', 'description': 'Instruments used to implant orthopedics prostheses\n', 'gmdn': 'na'}, {'tradeName': ' Control ™ Cable Cable & Sleeve – Cobalt Chrome', 'description': 'Instruments used to implant orthopedics prostheses\n', 'gmdn': 'NA'}]
About this record
Access comprehensive regulatory information for Sigma® Tibial Insert Rotating Platform STABILIZED in the Saudi Arabia medical device market through Pure Global AI's free database. This Class III device is registered with Saudi Arabia SFDA under registration number ME0000003224SFDAA00472 and manufactured by DePuy Orthopaedics, Inc..
This page provides complete registration details including product category (Medical Device), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
Free DatabasePowered by Pure Global AISFDA Official DataClass III