CAPSTONE CONTROL™ Spinal System

GUDID 00643169109018

SPACER 4011722 12 DEG 17X22

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00643169109018
• NIH Device Record Key: fa2834ec-a8f5-45b5-af6d-0a62b14bfbcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPSTONE CONTROL™ Spinal System
• Version Model Number: 4011722
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter
• Angle: 12 degree
• Outer Diameter: 17 Millimeter
• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169109018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120368

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: 2015-06-25

On-Brand Devices [CAPSTONE CONTROL™ Spinal System]

• 00643169109827: SPACER 4001427 6 DEG 14X27
• 00643169109810: SPACER 4001422 6 DEG 14X22
• 00643169109803: SPACER 4001332 6 DEG 13X32
• 00643169109797: SPACER 4001327 6 DEG 13X27
• 00643169109780: SPACER 4001322 6 DEG 13X22
• 00643169109773: SPACER 4001232 6 DEG 12X32
• 00643169109766: SPACER 4001227 6 DEG 12X27
• 00643169109759: SPACER 4001222 6 DEG 12X22
• 00643169109742: SPACER 4001132 6 DEG 11X32
• 00643169109735: SPACER 4001127 6 DEG 11X27
• 00643169109728: SPACER 4001122 6 DEG 11X22
• 00643169109711: SPACER 4001027 6 DEG 10X27
• 00643169109704: SPACER 4001022 6 DEG 10X22
• 00643169109667: SPACER 4001732 6 DEG 17X32
• 00643169109650: SPACER 4001727 6 DEG 17X27
• 00643169109643: SPACER 4001722 6 DEG 17X22
• 00643169109636: SPACER 4001632 6 DEG 16X32
• 00643169109629: SPACER 4001627 6 DEG 16X27
• 00643169109612: SPACER 4001622 6 DEG 16X22
• 00643169109605: SPACER 4001532 6 DEG 15X32
• 00643169109599: SPACER 4001527 6 DEG 15X27
• 00643169109582: SPACER 4001522 6 DEG 15X22
• 00643169109575: SPACER 4001432 6 DEG 14X32
• 00643169109094: SPACER 4021622 18 DEG 16X22
• 00643169109087: SPACER 4021522 18 DEG 15X22
• 00643169109070: SPACER 4011222 12 DEG 12X22
• 00643169109063: SPACER 4011122 12 DEG 11X22
• 00643169109056: SPACER 4011022 12 DEG 10X22
• 00643169109049: SPACER 4021422 18 DEG 14X22
• 00643169109032: SPACER 4021322 18 DEG 13X22
• 00643169109018: SPACER 4011722 12 DEG 17X22
• 00643169109001: SPACER 4011622 12 DEG 16X22
• 00643169108998: SPACER 4011522 12 DEG 15X22
• 00643169108981: SPACER 4011422 12 DEG 14X22
• 00643169108974: SPACER 4011322 12 DEG 13X22
• 00643169108967: SPACER 4021722 18 DEG 17X22
• 00643169108943: SPACER 4021727 18 DEG 17X27
• 00643169108936: SPACER 4021627 18 DEG 16X27
• 00643169108929: SPACER 4021527 18 DEG 15X27
• 00643169108912: SPACER 4021427 18 DEG 14X27
• 00643169108899: SPACER 4011727 12 DEG 17X27
• 00643169108882: SPACER 4011627 12 DEG 16X27
• 00643169108875: SPACER 4011527 12 DEG 15X27
• 00643169108868: SPACER 4011427 12 DEG 14X27
• 00643169108851: SPACER 4011327 12 DEG 13X27
• 00643169108844: SPACER 4011227 12 DEG 12X27
• 00643169092129: TRAY 3990052 SPREADER TRIALS- 2
• 00643169092112: TRAY 3990051 SPREADER TRIALS- 1
• 00643169092105: TRAY 3990050 GENERAL INSTRUMENTS
• 00643169055759: SPACER 3991327 CAPSTONE IR 0 DEG 13X27