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Sigma High Performance Partial Knee Femoral Unicondylar - SFDA Registration ME0000003224SFDAA00473

Access comprehensive regulatory information for Sigma High Performance Partial Knee Femoral Unicondylar 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 ME0000003224SFDAA00473 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
ME0000003224SFDAA00473
Sigma High Performance Partial Knee Femoral Unicondylar
SFDA Registration: ME0000003224SFDAA00473
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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
ME0000003224SFDAA00473
Authorization ID
MDMA-1-2019-1851
Status
Active
Expire Date
May 26, 2027
Manufacturer
Manufacturer Name
DePuy Orthopaedics, Inc.
Model Information
Model ID(s)
102407100 102407200 102407300 102407400 102407500 102407600 102408100 102408200 102408300 102408400 102408500 102408600 102451100 102451200 102451300 102451400 102451500 102451600 102452100 102452200 102452300 102452400 102452500 102452600 102453107 102453108 102453109 102453110 102453111 102453207 102453208 102453209 102453210 102453211 102453307 102453308 102453309 102453310 102453311 102453407 102453408 102453409 102453410 102453411 102453507 102453508 102453509 102453510 102453511 102453607 102453608 102453609 102453610 102453611 102454107 102454108 102454109 102454110 102454111 102454207 102454208 102454209 102454210 102454211 102454307 102454308 102454309 102454310 102454311 102454407 102454408 102454409 102454410 102454411 102454507 102454508 102454509 102454510 102454511 102454607 102454608 102454609 102454610 102454611 102411108 102411109 102411110 102411111 102411208 102411209 102411210 102411211 102411308 102411309 102411310 102411311 102411408 102411409 102411410 102411411 102411508 102411509 102411510 102411511 102411608 102411609 102411610 102411611 102412108 102412109 102412110 102412111 102412208 102412209 102412210 102412211 102412308 102412309 102412310 102412311 102412408 102412409 102412410 102412411 102412508 102412509 102412510 102412511 102412608 102412609 102412610 102412611
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