SOVEREIGN™ Spinal System

GUDID 00643169659476

SPACER 78692418 SV PTC L 42X30X18 24D CP

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00643169659476
• NIH Device Record Key: fe0f7c6a-15d7-4e97-a7c8-ddf226b65f0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOVEREIGN™ Spinal System
• Version Model Number: 78692418
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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
• 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 Dimensions

• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter
• Height: 18 Millimeter
• Width: 30 Millimeter
• Length: 42 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169659476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172328

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

[00643169659476]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-02

On-Brand Devices [SOVEREIGN™ Spinal System]

• 00613994736611: SCREW 7975520 SOVEREIGN FA 5.5 X 20MM
• 00613994736598: SCREW 7975525 SOVEREIGN FA 5.5 X 25MM
• 00613994736574: SCREW 7975530 SOVEREIGN FA 5.5 X 30MM
• 00613994736550: SCREW 7975535 SOVEREIGN FA 5.5 X 35MM
• 00613994736536: SCREW 7976020 SOVEREIGN FA 6.0 X 20MM
• 00613994736512: SCREW 7976025 SOVEREIGN FA 6.0 X 25MM
• 00613994736499: SCREW 7976030 SOVEREIGN FA 6.0 X 30MM
• 00613994736475: SCREW 7976035 SOVEREIGN FA 6.0 X 35MM
• 00613994545329: SHAFT 7967081 L INSERTER
• 00613994545312: SHAFT 7967080 M INSERTER
• 00613994545305: SHAFT 7967079 S INSERTER
• 00613994513489: SCREW Y7966030 6.0 X 30MM SELF-TAP
• 00613994513472: SCREW Y7966025 6.0 X 25MM SELF-TAP
• 00613994513458: SCREW Y7965525 5.5 X 25MM SELF-TAP
• 00613994504234: SPACER Y7968816 M 37X27X 16MM, 8 DEG
• 00613994504227: SPACER Y7968814 M 37X27X 14MM, 8 DEG
• 00613994504210: SPACER Y7968812 M 37X27X 12MM, 8 DEG
• 00613994504203: COVERPLATE Y7968330 MEDIUM
• 00613994504197: SPACER Y7967816 S 32X23X 16MM, 8 DEG
• 00613994504180: SPACER Y7967814 S 32X23X 14MM, 8 DEG
• 00613994504173: SPACER Y7967812 S 32X23X 12MM, 8 DEG
• 00613994504166: COVERPLATE Y7967330 SMALL
• 00613994501929: SCREW 7966035 6.0MM X 35MM SELF TAP
• 00613994501912: SCREW 7966030 6.0MM X 30MM SELF TAP
• 00613994501905: SCREW 7966025 6.0MM X 25MM SELF TAP
• 00613994501899: SCREW 7966020 6.0MM X 20MM SELF TAP
• 00613994501875: SCREW 7965535 5.5MM X 35MM SELF TAP
• 00613994501868: SCREW 7965530 5.5MM X 30MM SELF TAP
• 00613994501851: SCREW 7965525 5.5MM X 25MM SELF TAP
• 00613994501844: SCREW 7965520 5.5MM X 20MM SELF TAP
• 00613994501004: ASSEMBLY 7967210 S 32X23 10MM 12DEG CP
• 00613994500991: ASSEMBLY 7967212 S 32X23 12MM 12DEG CP
• 00613994500984: ASSEMBLY 7967214 S 32X23 14MM 12DEG CP
• 00613994500977: SPACER 7967216 S 32 X 23 X16MM 12 DEG
• 00613994500960: ASSEMBLY 7967218 S 32X23 18MM 12DEG CP
• 00613994500953: SPACER 7967220 S 32 X 23 X20MM 12 DEG
• 00613994500946: ASSEMBLY 7967222 S 32X23 22MM 12DEG CP
• 00613994500939: SPACER 7967224 S 32 X 23 X24MM 12 DEG
• 00613994500922: SPACER 7967810 S 32 X 23 X10MM 8 DEG
• 00613994500915: ASSEMBLY 7967812 S 32X23 12MM 8DEG CP
• 00613994500908: SPACER 7967814 S 32 X 23 X14MM 8 DEG
• 00613994500892: ASSEMBLY 7967816 S 32X23 16MM 8DEG CP
• 00613994500885: ASSEMBLY 7967818 S 32X23 18MM 8DEG CP
• 00613994500878: ASSEMBLY 7967820 S 32X23 20MM 8DEG CP
• 00613994500861: ASSEMBLY 7967822 S 32X23 22MM 8DEG CP
• 00613994500854: SPACER 7967824 S 32 X 23 X24MM 8 DEG
• 00613994321176: SHAFT 7967007 S INSERTER
• 00613994321169: SHAFT 7967008 M INSERTER
• 00613994321152: SHAFT 7967009 L INSERTER
• 00613994321121: INSERTER 7967012 CP