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Oracle Cage - SFDA Registration ME0000000735SFDAA00162

Access comprehensive regulatory information for Oracle Cage in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIb device is registered with Saudi Arabia SFDA under registration number ME0000000735SFDAA00162 and manufactured by Synthes GmbH.

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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SFDA Official Data
Class IIb
ME0000000735SFDAA00162
Oracle Cage
SFDA Registration: ME0000000735SFDAA00162
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Product Information

Implant system for lateral interbody fusion in the lumbar spine

Product Use

The device is intended for: To replace lumbar intervertebral discs and to fuse the adjacent vertebral bodies together at vertebral levels L1 to L5.

Device Classification
Risk Class
Class IIb
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000000735SFDAA00162
Authorization ID
GHTF-2015-1465
Status
Active
Expire Date
December 22, 2017
Manufacturer
Manufacturer Name
Synthes GmbH
Model Information
Model ID(s)
08.809.211S 08.809.611S 08.809.213S 08.809.613S 08.809.215S 08.809.615S 08.809.217S 08.809.617S 08.809.209S 08.809.609S 08.809.231S 08.809.631S 08.809.233S 08.809.633S 08.809.235S 08.809.635S 08.809.237S 08.809.637S 08.809.229S 08.809.629S 08.809.251S 08.809.651S 08.809.253S 08.809.653S 08.809.255S 08.809.655S 08.809.257S 08.809.657S 08.809.249S 08.809.649S 08.809.271S 08.809.671S 08.809.273S 08.809.673S 08.809.275S 08.809.675S 08.809.277S 08.809.677S 08.809.269S 08.809.669S
Product Accessories

[{'tradeName': 'Kirschner Wire', 'description': None, 'gmdn': '35685'}, {'tradeName': 'Light Clip f/Oracle Retractor', 'description': None, 'gmdn': '32241'}, {'tradeName': 'Ball Tip Probe', 'description': None, 'gmdn': '15275'}, {'tradeName': 'Bipolar Forceps', 'description': None, 'gmdn': '42894'}, {'tradeName': 'Dilator', 'description': None, 'gmdn': '35315'}, {'tradeName': 'Dissector', 'description': None, 'gmdn': '11290'}, {'tradeName': 'Handle', 'description': None, 'gmdn': '47829'}, {'tradeName': 'Implant Holder f/Oracle Cage', 'description': None, 'gmdn': '47807'}, {'tradeName': 'Long Suction Instrument', 'description': None, 'gmdn': '47865'}, {'tradeName': 'Oracle Curette', 'description': None, 'gmdn': '47022'}, {'tradeName': 'Oracle Dilator', 'description': None, 'gmdn': '35315'}, {'tradeName': 'Oracle Gouge', 'description': None, 'gmdn': '10825'}, {'tradeName': 'Oracle Impactor', 'description': None, 'gmdn': '32856'}, {'tradeName': 'Oracle Implant Remover', 'description': None, 'gmdn': '47807'}, {'tradeName': 'Oracle Lateral Quick Inserter Distractor', 'description': None, 'gmdn': '44378'}, {'tradeName': 'Oracle Rasp', 'description': None, 'gmdn': '35559'}, {'tradeName': 'Oracle Retractor Blade Extension', 'description': None, 'gmdn': '46774'}, {'tradeName': 'Oracle Retractor Blade', 'description': None, 'gmdn': '46774'}, {'tradeName': 'Oracle Retractor Handle', 'description': None, 'gmdn': '47829'}, {'tradeName': 'Oracle Retractor Intradiscal Anchor', 'description': None, 'gmdn': '46774'}, {'tradeName': 'Oracle Ring Curette, bayoneted', 'description': None, 'gmdn': '47022'}, {'tradeName': 'Oracle Shaver', 'description': None, 'gmdn': '35541'}, {'tradeName': 'Oracle Spreader', 'description': None, 'gmdn': '44378'}, {'tradeName': 'Oracle Trial Implant', 'description': None, 'gmdn': '44788'}, {'tradeName': 'Periosteal Elevator', 'description': None, 'gmdn': '35048'}, {'tradeName': 'Retractor Blade Screwdriver', 'description': None, 'gmdn': '33968'}, {'tradeName': 'Retractor Pin', 'description': None, 'gmdn': '44759'}, {'tradeName': 'Rongeur f/Intervertebral Discs', 'description': None, 'gmdn': '32853'}, {'tradeName': 'Screwdriver, hexagonal', 'description': None, 'gmdn': '33968'}, {'tradeName': 'Soft Tissue Retractor', 'description': None, 'gmdn': '46774'}, {'tradeName': 'Table Clamp f/Universal Arm', 'description': None, 'gmdn': '35967'}, {'tradeName': 'Tissue Dissector', 'description': None, 'gmdn': '11290'}, {'tradeName': 'Universal Arm', 'description': None, 'gmdn': '47786'}]