Saudi Arabia SFDA registration ME0000003224SFDAA00491
Sigma® Tibial Component All Poly Stabilized
Saudi Arabia·Medical Device·DePuy Orthopaedics, Inc.·Class IIIActiveProduct information
Knee Prosthesis
Product use
Candidates for total or uni-compartmental knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. In candidates for uni-compartmental knee Arthroplasty, only one side of the joint (the medial or lateral compartment) is affected.
Device classification
- Risk Class
- Class III
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000003224SFDAA00491
- Authorization ID
- MDMA-1-2019-1852
- Status
- Active
- Expire Date
- September 01, 2026
Manufacturer
- Manufacturer Name
- DePuy Orthopaedics, Inc.
Model information
- Model ID(s)
- 962660, 962661, 962662, 962663.
Product accessories
[{'tradeName': ' LCS® Completion® REV Femoral Tapered Reamer', 'description': 'Knee System', 'gmdn': 'NA'}, {'tradeName': ' Sigma® LCS® Sterile Threaded Pins', 'description': '\nTotal Knee System', 'gmdn': 'NA'}, {'tradeName': ' Sigma® LCS® Quick Drill Pins', 'description': '\nTotal Knee System', 'gmdn': 'NA'}, {'tradeName': ' Sigma® LCS® Threaded Pins', 'description': 'Total Knee System', 'gmdn': 'NA'}]
About this record
Access comprehensive regulatory information for Sigma® Tibial Component All Poly 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 ME0000003224SFDAA00491 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