Saudi Arabia SFDA registration ME0000000280SFDAA00103
KyphOs FS Calcium Phosphate Bone Substitute
Saudi Arabia·Medical Device·Medtronic Sofamor Danek USA, Inc.·Class IIIActiveProduct information
Synthetic Bone Grafts
Product use
KyphOs™ FS Bone Substitute is a sterile, osteoconductive bone substitute material based on inorganic calcium phosphate salts. The powder component consists of calcium and phosphate salts and the starter solution consists of an aqueous phosphate solution. KyphOs™ FS Bone Substitute contains no materials of human or animal origin.
Device classification
- Risk Class
- Class III
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000000280SFDAA00103
- Authorization ID
- GHTF-2015-0151
- Status
- Active
- Expire Date
- November 24, 2018
Manufacturer
- Manufacturer Name
- Medtronic Sofamor Danek USA, Inc.
Model information
- Model ID(s)
- C02B
Product accessories
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About this record
Access comprehensive regulatory information for KyphOs FS Calcium Phosphate Bone Substitute 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 ME0000000280SFDAA00103 and manufactured by Medtronic Sofamor Danek USA, 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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