ELEVATE™ Spinal System

GUDID 00643169771017

INSERTER NAV2134 DRIVE SHAFT

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00643169771017
• NIH Device Record Key: 384517f3-f0bb-4ddb-b47a-3dc512906e8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELEVATE™ Spinal System
• Version Model Number: NAV2134
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169771017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163581

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

[00643169771017]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-01-26

On-Brand Devices [ELEVATE™ Spinal System]

• 00643169844070: TRAY NAV2143 EXP NAV POST DISC PREP INST
• 00643169771024: INSERTER NAV2133 INNER LOCKING TUBE
• 00643169771017: INSERTER NAV2134 DRIVE SHAFT
• 00643169771000: INSERTER NAV2132 ELEVATE
• 00643169764880: TRAY NAV2043 NAV ELEVATE INSTR
• 00643169432246: DISTRACTOR 4 8657008 ELEVATE
• 00643169432239: DISTRACTOR 3 8657007 ELEVATE
• 00643169432222: DISTRACTOR 2 8657006 ELEVATE
• 00643169432215: DISTRACTOR 1 8657005 ELEVATE
• 00643169432192: INSERTER DRIVE SHAFT 8657003 ELEVATE
• 00643169432185: INSTR INNR LOCKING TUBE 8657002 ELEVATE
• 00643169432178: INSERTER 8657001 ELEVATE
• 00643169430884: SPACER 8881132 ELEVATE X-LOR 32X11MM
• 00643169430877: SPACER 8881032 ELEVATE X-LOR 32X10MM
• 00643169430860: SPACER 8880932 ELEVATE X-LOR 32X9MM
• 00643169430853: SPACER 8880832 ELEVATE X-LOR 32X8MM
• 00643169430846: SPACER 8881128 ELEVATE X-LOR 28X11MM
• 00643169430839: SPACER 8881028 ELEVATE X-LOR 28X10MM
• 00643169430822: SPACER 8880928 ELEVATE X-LOR 28X9MM
• 00643169430815: SPACER 8880828 ELEVATE X-LOR 28X8MM
• 00643169430808: SPACER 8881123 ELEVATE X-LOR 23X11MM
• 00643169430792: SPACER 8881023 ELEVATE X-LOR 23X10MM
• 00643169430785: SPACER 8880923 ELEVATE X-LOR 23X9MM
• 00643169430778: SPACER 8880823 ELEVATE X-LOR 23X8MM
• 00643169430761: SPACER 7771132 ELEVATE STD 32X11MM
• 00643169430754: SPACER 7771032 ELEVATE STD 32X10MM
• 00643169430747: SPACER 7770932 ELEVATE STD 32X9MM
• 00643169430730: SPACER 7770832 ELEVATE STD 32X8MM
• 00643169430723: SPACER 7770732 ELEVATE X-LOR 32X7MM
• 00643169430716: SPACER 7771128 ELEVATE STD 28X11MM
• 00643169430709: SPACER 7771028 ELEVATE STD 28X10MM
• 00643169430693: SPACER 7770928 ELEVATE STD 28X9MM
• 00643169430686: SPACER 7770923 ELEVATE STD 23X9MM
• 00643169430679: SPACER 7771023 ELEVATE STD 23X10MM
• 00643169430662: SPACER 7771123 ELEVATE STD 23X11MM
• 00643169430655: SPACER 7770728 ELEVATE X-LOR 28X7MM
• 00643169430648: SPACER 7770828 ELEVATE STD 28X8MM
• 00643169430440: SPACER 7770823 ELEVATE STD 23X8MM
• 00643169430433: SPACER 7770723 ELEVATE X-LOR 23X7MM
• 00763000124717: NAV TRIAL 11MM NAV2141 ELEVATE
• 00763000141424: INSERTER NAV2134 DRIVE SHAFT
• 00763000141417: INSERTER NAV2133 INNER LOCKING TUBE
• 00763000141400: INSERTER NAV2132 ELEVATE
• 00763000880385: INSERTER NAV2132 ELEVATE
• 00763000880408: INSERTER NAV2134 DRIVE SHAFT
• 00763000880392: INSERTER NAV2133 INNER LOCKING TUBE