CD HORIZON ESSENTIALS™ Spinal System

GUDID 20643169490707

ROD 5570ROD2PER PRE-BENT 5.5X70 TI STER

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 20643169490707
• NIH Device Record Key: d12c2e4d-4165-46ea-996c-df5feb6b4dfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD HORIZON ESSENTIALS™ Spinal System
• Version Model Number: 5570ROD2PER
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 2
• 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: 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169490703 [Unit of Use]
GS1	20643169490707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142847

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-17

On-Brand Devices [CD HORIZON ESSENTIALS™ Spinal System]

• 00643169603493: SCREW KIT E7545MASKIT ESSENCE MAS 7.5X45
• 00643169603486: SCREW KIT E7540MASKIT ESSENCE MAS 7.5X40
• 00643169603455: SCREW KIT E6550MASKIT ESSENCE MAS 6.5X50
• 00643169603448: SCREW KIT E6545MASKIT ESSENCE MAS 6.5X45
• 00643169603431: SCREW KIT E6540MASKIT ESSENCE MAS 6.5X40
• 00643169603424: SCREW KIT E6535MASKIT ESSENCE MAS 6.5X35
• 00643169603387: SCREW KIT E5540MASKIT ESSENCE MAS 5.5X40
• 00643169595132: TRAY 7377004 SDS TL INTERBODY INS
• 00643169595125: TRAY 7377003 SDS TL DISC PREP INS
• 00643169595118: TRAY 7377002 SDS TL FIXATION INS 2 OF 2
• 00643169595101: TRAY 7377001 SDS TL FIXATION INS 1 OF 2
• 00643169429062: SCRW 45340006540 ESSENCE STRLEMAS6.5X40
• 00643169428959: SCRW 45340007545 ESSENCE STRLEMAS7.5X45
• 00643169428928: SET SCRW 4530020 ESSENCE STRL BREAK-OFF
• 20643169490707: ROD 5570ROD2PER PRE-BENT 5.5X70 TI STER
• 20643169490691: ROD 5560ROD2PER PRE-BENT 5.5X60 TI STER
• 20643169490684: ROD 5550ROD2PER PRE-BENT 5.5X50 TI STER
• 20643169490677: ROD 5540ROD2PER PRE-BENT 5.5X40 TI STER
• 20643169490660: ROD 5535ROD2PER PRE-BENT 5.5X35 TI STER