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Sigma® Tibial Component All Poly Stabilized - SFDA Registration ME0000003224SFDAA00491

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.

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Class III
ME0000003224SFDAA00491
Sigma® Tibial Component All Poly Stabilized
SFDA Registration: ME0000003224SFDAA00491
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Product 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'}]