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Sigmaยฎ Tibial Insert Rotating Platform STABILIZED - SFDA Registration ME0000003224SFDAA00472

Access comprehensive regulatory information for Sigmaยฎ 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.

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Class III
ME0000003224SFDAA00472
Sigmaยฎ Tibial Insert Rotating Platform STABILIZED
SFDA Registration: ME0000003224SFDAA00472
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Product 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 ยฎ APG+ Low Profile Central Reamer', 'description': 'Instruments used to implant orthopedics prostheses\n', 'gmdn': 'NA'}, {'tradeName': ' Control โ„ข Cable Sleeve โ€“ Cobalt Chrome', 'description': 'Instruments used to implant orthopedics prostheses\n', 'gmdn': 'na'}, {'tradeName': ' Control โ„ข Cable Cable & Sleeve โ€“ Cobalt Chrome', 'description': 'Instruments used to implant orthopedics prostheses\n', 'gmdn': 'NA'}]