CD Horizon™ ModuLeX™ FNS Screw Set

GUDID 00763000658465

SHANK 55901528550 CAN OG FNS 8.5X50 TI S

MEDTRONIC SOFAMOR DANEK, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00763000658465
• NIH Device Record Key: ac983f51-e861-4d92-b706-afad320fb9f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD Horizon™ ModuLeX™ FNS Screw Set
• Version Model Number: 55901528550
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000658465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232141

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-06
• Device Publish Date: 2024-12-29

On-Brand Devices [CD Horizon™ ModuLeX™ FNS Screw Set]

• 00763000866433: 2PK SHANK 55902528555 CN OG FNS 8.5X55 S
• 00763000866426: 2PK SHANK 55902528550 CN OG FNS 8.5X50 S
• 00763000866419: 2PK SHANK 55902528545 CN OG FNS 8.5X45 S
• 00763000866402: 2PK SHANK 55902527555 CN OG FNS 7.5X55 S
• 00763000866396: 2PK SHANK 55902527550 CN OG FNS 7.5X50 S
• 00763000866389: 2PK SHANK 55902527545 CN OG FNS 7.5X45 S
• 00763000866372: 2PK SHANK 55902527540 CN OG FNS 7.5X40 S
• 00763000866365: 2PK SHANK 55902527535 CN OG FNS 7.5X35 S
• 00763000866358: 2PK SHANK 55902526560 CN OG FNS 6.5X60 S
• 00763000866341: 2PK SHANK 55902526555 CN OG FNS 6.5X55 S
• 00763000866334: 2PK SHANK 55902526550 CN OG FNS 6.5X50 S
• 00763000866327: 2PK SHANK 55902526545 CN OG FNS 6.5X45 S
• 00763000866310: 2PK SHANK 55902526540 CN OG FNS 6.5X40 S
• 00763000866303: 2PK SHANK 55902526535 CN OG FNS 6.5X35 S
• 00763000866297: 2PK SHANK 55902525555 CN OG FNS 5.5X55 S
• 00763000866280: 2PK SHANK 55902525550 CN OG FNS 5.5X50 S
• 00763000866273: 2PK SHANK 55902525545 CN OG FNS 5.5X45 S
• 00763000866266: 2PK SHANK 55902525540 CN OG FNS 5.5X40 S
• 00763000866259: 2PK SHANK 55902525535 CN OG FNS 5.5X35 S
• 00763000866242: 2PK SHANK 55902524550 CN OG FNS 4.5X50 S
• 00763000866235: 2PK SHANK 55902524545 CN OG FNS 4.5X45 S
• 00763000866228: 2PK SHANK 55902524540 CN OG FNS 4.5X40 S
• 00763000764777: TRAY 5597900 MDLX NS FENESTRATED SHANKS
• 00763000661403: SHANK 55901529565 CAN OG FNS 9.5X65 TI S
• 00763000661397: SHANK 55901529560 CAN OG FNS 9.5X60 TI S
• 00763000661380: SHANK 55901529555 CAN OG FNS 9.5X55 TI S
• 00763000661373: SHANK 55901529550 CAN OG FNS 9.5X50 TI S
• 00763000661366: SHANK 55901529545 CAN OG FNS 9.5X45 TI S
• 00763000661359: SHANK 55901529540 CAN OG FNS 9.5X40 TI S
• 00763000661342: SHANK 55901529535 CAN OG FNS 9.5X35 TI S
• 00763000661304: SHANK 55901521565 CN OG FNS 10.5X65 TI S
• 00763000661298: SHANK 55901521560 CN OG FNS 10.5X60 TI S
• 00763000661281: SHANK 55901521555 CN OG FNS 10.5X55 TI S
• 00763000658496: SHANK 55901528565 CAN OG FNS 8.5X65 TI S
• 00763000658489: SHANK 55901528560 CAN OG FNS 8.5X60 TI S
• 00763000658472: SHANK 55901528555 CAN OG FNS 8.5X55 TI S
• 00763000658465: SHANK 55901528550 CAN OG FNS 8.5X50 TI S
• 00763000658458: SHANK 55901528545 CAN OG FNS 8.5X45 TI S
• 00763000658441: SHANK 55901528540 CAN OG FNS 8.5X40 TI S
• 00763000658434: SHANK 55901528535 CAN OG FNS 8.5X35 TI S
• 00763000658427: SHANK 55901528530 CAN OG FNS 8.5X30 TI S
• 00763000658410: SHANK 55901527580 CAN OG FNS 7.5X80 TI S
• 00763000658403: SHANK 55901527575 CAN OG FNS 7.5X75 TI S
• 00763000658397: SHANK 55901527570 CAN OG FNS 7.5X70 TI S
• 00763000658380: SHANK 55901527565 CAN OG FNS 7.5X65 TI S
• 00763000658373: SHANK 55901527560 CAN OG FNS 7.5X60 TI S
• 00763000658366: SHANK 55901527555 CAN OG FNS 7.5X55 TI S
• 00763000658359: SHANK 55901527550 CAN OG FNS 7.5X50 TI S
• 00763000658342: SHANK 55901527545 CAN OG FNS 7.5X45 TI S
• 00763000658335: SHANK 55901527540 CAN OG FNS 7.5X40 TI S