Saudi Arabia SFDA registration ME0000003224SFDAA00457
Sigma Tibial Insert Rotating Platform TC3
Saudi Arabia·Medical Device·DePuy Orthopaedics, Inc.·Class IIIActiveProduct information
Replacement of the knee joint
Product use
Total Knee System consists of three components intended to replace the femoral,
tibial, and patellar articular surfaces of the knee joint.
Device classification
- Risk Class
- Class III
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000003224SFDAA00457
- Authorization ID
- MDMA-1-2019-1851
- Status
- Active
- Expire Date
- May 26, 2027
Manufacturer
- Manufacturer Name
- DePuy Orthopaedics, Inc.
Model information
- Model ID(s)
- 962311 962312 962313 962314 962315 962316 962317 962318 962321 962322 962323 962324 962325 962326 962327 962328 962331 962332 962333 962334 962335 962336 962337 962338 962341 962342 962343 962344 962345 962346 962347 962348 962351 962352 962353 962354 962355 962356 962357 962358 962361 962362 962363 962364 962365 962366 962367 962368
Product accessories
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About this record
Access comprehensive regulatory information for Sigma Tibial Insert Rotating Platform 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 ME0000003224SFDAA00457 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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