CRESCENT™ Spinal System

GUDID 00613994485113

SPACER 6660830 CRESCENT TI

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00613994485113
• NIH Device Record Key: 084c0ef1-bc95-434e-b2a0-fd355ad8e51a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRESCENT™ Spinal System
• Version Model Number: 6660830
• 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: 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

Device Dimensions

• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter
• Length: 30 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994485113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110543

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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: 2015-08-21

On-Brand Devices [CRESCENT™ Spinal System]

• 00613994523518: SPACER 6661636 CRESCENT TI
• 00613994523501: SPACER 6661630 CRESCENT TI
• 00613994523495: SPACER 6661625 CRESCENT TI
• 00613994523419: IMPACTOR 6661516 CRESCENT TI 15/16MM
• 00613994523402: IMPACTOR 6661314 CRESCENT TI 13/14MM
• 00613994523396: IMPACTOR 6661112 CRESCENT TI 11/12MM
• 00613994523389: IMPACTOR 6660910 CRESCENT TI 9/10MM
• 00613994523372: IMPACTOR 6660078 CRESCENT TI 7/8 MM
• 00613994523365: SPACER 6671230 CRESCENT TI
• 00613994523358: SPACER 6671236 CRESCENT TI
• 00613994523341: SPACER 6671330 CRESCENT TI
• 00613994523334: SPACER 6671336 CRESCENT TI
• 00613994523327: SPACER 6671430 CRESCENT TI
• 00613994523310: SPACER 6671436 CRESCENT TI
• 00613994523303: SPACER 6671530 CRESCENT TI
• 00613994523297: SPACER 6671536 CRESCENT TI
• 00613994523280: SPACER 6671630 CRESCENT TI
• 00613994523273: SPACER 6671636 CRESCENT TI
• 00613994518026: ASSEMBLY 7969210 L 42X30 10MM 12 DEG CP
• 00613994518002: SPACER 7969212 L 42 X 30 X 12MM 12 DEG
• 00613994517982: SPACER 7969214 L 42 X 30 X 14MM 12 DEG
• 00613994517968: ASSEMBLY 7969216 L 42X30 16MM 12 DEG CP
• 00613994517951: ASSEMBLY 7969218 L 42X30 18MM 12 DEG CP
• 00613994517937: SPACER 7969220 L 42 X 30 X 20MM 12 DEG
• 00613994517913: ASSEMBLY 7969222 L 42X30 22MM 12 DEG CP
• 00613994517890: ASSEMBLY 7969224 L 42X30 24MM 12 DEG CP
• 00613994517883: ASSEMBLY 7969810 L 42X30 10MM 8 DEG CP
• 00613994517876: SPACER 7969812 L 42 X 30 X 12MM 8 DEG
• 00613994517869: ASSEMBLY 7969814 L 42X30 14MM 8 DEG CP
• 00613994517852: SPACER 7969816 L 42 X 30 X 16MM 8 DEG
• 00613994517845: ASSEMBLY 7969818 L 42X30 18MM 8 DEG CP
• 00613994517838: ASSEMBLY 7969820 L 42X30 20MM 8 DEG CP
• 00613994517821: ASSEMBLY 7969822 L 42X30 22MM 8 DEG CP
• 00613994517814: SPACER 7969824 L 42 X 30 X 24MM 8 DEG
• 00613994517807: ASSEMBLY 7968210 M 37X27 10MM 12 DEG CP
• 00613994517791: ASSEMBLY 7968212 M 37X27 12MM 12 DEG CP
• 00613994517784: ASSEMBLY 7968214 M 37X27 14MM 12 DEG CP
• 00613994517777: ASSEMBLY 7968216 M 37X27 16MM 12 DEG CP
• 00613994517760: ASSEMBLY 7968218 M 37X27 18MM 12 DEG CP
• 00613994517753: ASSEMBLY 7968220 M 37X27 20MM 12 DEG CP
• 00613994517746: SPACER 7968222 M 37 X 27 X22MM 12 DEG
• 00613994517739: SPACER 7968224 M 37 X 27 X24MM 12 DEG
• 00613994517722: ASSEMBLY 7968810 M 37X27 10MM 8 DEG CP
• 00613994517715: ASSEMBLY 7968812 M 37X27 12MM 8 DEG CP
• 00613994517708: SPACER 7968814 M 37 X 27 X14MM 8 DEG
• 00613994517692: ASSEMBLY 7968816 M 37X27 16MM 8 DEG CP
• 00613994517685: ASSEMBLY 7968818 M 37X27 18MM 8 DEG CP
• 00613994517678: ASSEMBLY 7968820 M 37X27 20MM 8 DEG CP
• 00613994517661: ASSEMBLY 7968822 M 37X27 22MM 8 DEG CP
• 00613994517654: SPACER 7968824 M 37 X 27 X24MM, 8 DEG