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RELINE-O X-Conn - SFDA Registration ME0000005437SFDAA00131

Access comprehensive regulatory information for RELINE-O X-Conn 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 ME0000005437SFDAA00131 and manufactured by NuVasive Inc..

This page provides complete registration details including product category (MD), 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
ME0000005437SFDAA00131
RELINE-O X-Conn
SFDA Registration: ME0000005437SFDAA00131
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Product Information

Non sterile bone screw internal spinal fixation system.

Product Use

System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine

Device Classification
Risk Class
Class IIb
Product Category
MD
Product Type
MD
Registration Information
Registration ID
ME0000005437SFDAA00131
Authorization ID
MDMA-1-2021-1484
Status
Active
Expire Date
May 26, 2024
Manufacturer
Manufacturer Name
NuVasive Inc.
Model Information
Model ID(s)
10050320 10050322 10050325 10050327 10050330 10050332 10050335 10055322 10055325 10055327 10055330 10055332 10055335 10055340 10055345 10055350 10055355 10055320 10060320 10060322 10060325 10060327 10060330 10060332 10060335 10060340 10050430 10050435 10050440 10050445 10055430 10055435 10055440 10055445 10055455 10056430 10056435 10056440 10056445 10056455 10060430 10060435 10060440 10060445 10060455
Product Accessories

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'RELINE-O LS Starter, 1/4" Sq Long', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Final Lock Screw Driver, Long', 'description': 'Reusable surgical screwdriver', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Final Lock Screw Driver', 'description': 'Reusable surgical screwdriver', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Compressor', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Distractor, Hinged', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Guide, 1-Level Open Top', 'description': 'Surgical instrument/implant depth limiter', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Counter Torque,Open Top Guide', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O T-Handle, Reducer', 'description': 'Non torque limiting surgical instrument handle', 'gmdn': '64192'}, {'tradeName': 'RELINE-O X-Link T-Handle, 40 in-lb', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Measurement Tool, Cross Conn', 'description': 'Orthopaedic instrument dismantling device', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Derotation Clamp', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Handle, Facet Tube', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE Reducer, Matador', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE Final Lock Screw Driver', 'description': 'Reusable surgical screwdriver', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Tissue Dissector', 'description': 'Open-surgery dissector', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Screwdriver, Poly Cann', 'description': 'Reusable surgical screwdriver', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Inserter', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Chisel', 'description': 'Orthopaedic chisel', 'gmdn': '64192'}, {'tradeName': 'RELINE-O ASF Cobb', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Handle', 'description': 'Non torque limiting surgical instrument handle', 'gmdn': '64192'}, {'tradeName': 'NAV.S RELINE MAS Screwdriver, Poly Cann', 'description': 'Reusable surgical screwdriver', 'gmdn': '64192'}, {'tradeName': 'NAV.S RELINE Shankdriver, Cannulated', 'description': 'Reusable surgical screwdriver', 'gmdn': '64192'}, {'tradeName': 'RSS Gearshift Probe', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RSS Pedicle Probe', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RSS Tap', 'description': 'Reusable internal spinal fixation 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{'tradeName': 'RELINE MAS Guide', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Holder, K-Wire', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Handle, Fasical Blade', 'description': 'Non torque limiting surgical instrument handle', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Rod Inserter', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Reducer', 'description': 'Orthopaedic rod reducer', 'gmdn': '64192'}, {'tradeName': 'RELINE Lock Screw Starter, Expandable', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Screwdriver', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RSS Screwdriver', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RSS Holder, X-Connector', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Sleeve, Screwdriver Spring', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE Reduction Bell', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Reduction Bell', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Reduction Cap', 'description': ' Reusable internal spinal fixation procedure kit\n', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Tap/Dilator Combo', 'description': ' Reusable internal spinal fixation procedure kit\n', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Tap', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Quarter Sq Attachment, LS', 'description': ' Reusable internal spinal fixation procedure kit\n', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Handle, Dual Ended Straight', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Driver, Fixed Inserter', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Compressor', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Guide Extenders', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Guide', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': ' RELINE MAS Guide Tool, Acorn', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Tool, Guide Attachment', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Facet Tube', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS Guide Adjuster', 'description': ' Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Handle, Straight Long Ratchet', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE MAS T-Handle, 90 in-lb Torque', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Pedicle Probe, Dual Ball Tip', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE-O Lock Screw Starter', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}, {'tradeName': 'RELINE Rod Cutter, Table Top', 'description': 'Reusable internal spinal fixation procedure kit', 'gmdn': '64192'}]