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P.F.C Sigma Tibial Insert Fixed Bearing TC3 - SFDA Registration ME0000003224SFDAA00330

Access comprehensive regulatory information for P.F.C Sigma Tibial Insert Fixed Bearing TC3 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 ME0000003224SFDAA00330 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
ME0000003224SFDAA00330
P.F.C Sigma Tibial Insert Fixed Bearing TC3
SFDA Registration: ME0000003224SFDAA00330
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Product Information

femoral Component

Product Use

intended to 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
ME0000003224SFDAA00330
Authorization ID
GHTF-2018-1291
Status
Active
Expire Date
March 29, 2019
Manufacturer
Manufacturer Name
DePuy Orthopaedics, Inc.
Model Information
Model ID(s)
960500 960501 960502 960503 960504 960505 960506 960510 960511 960512 960513 960514 960515 960516 960517 960520 960521 960522 960523 960524 960525 960526 960527 960530 960531 960532 960533 960534 960535 960536 960537 960540 960541 960542 960543 960544 960545 960546 960547 960550 960551 960552 960553 960554 960555 960556 960557
Product Accessories

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