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KYPHONยฎ Bone Filler Device - SFDA Registration ME0000000280SFDAA00111

Access comprehensive regulatory information for KYPHONยฎ Bone Filler Device in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIa device is registered with Saudi Arabia SFDA under registration number ME0000000280SFDAA00111 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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Class IIa
ME0000000280SFDAA00111
KYPHONยฎ Bone Filler Device
SFDA Registration: ME0000000280SFDAA00111
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Product Information

Bone Filler Device

Product Use

The KYPHONยฎ Bone Filler Device and KYPHONยฎ EXPRESSโ„ข Bone Filler Device are intended for the delivery of bone cement, including use during a balloon kyphoplasty procedure.

Device Classification
Risk Class
Class IIa
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000000280SFDAA00111
Authorization ID
GHTF-2015-0152
Status
Active
Expire Date
April 19, 2023
Manufacturer
Model Information
Model ID(s)
F04B
Product Accessories

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