Capstone Control PTC Spinal System

GUDID 00643169679696

SPACER 4991432 CONTROL PTC 0 DEG 14X32

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00643169679696
• NIH Device Record Key: a9468796-15df-4ae2-8b16-aed37d131f33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capstone Control PTC Spinal System
• Version Model Number: 4991432
• 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: true
• 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

• Angle: 0 degree
• Angle: 0 degree
• Angle: 0 degree
• Angle: 0 degree
• Angle: 0 degree
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 32 Millimeter
• Angle: 0 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169679696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171107

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-02
• Device Publish Date: 2018-09-01

On-Brand Devices [Capstone Control PTC Spinal System]

• 00643169679993: SPACER 5001832 CONTROL PTC 6 DEG 18X32
• 00643169679986: SPACER 5001732 CONTROL PTC 6 DEG 17X32
• 00643169679979: SPACER 5001632 CONTROL PTC 6 DEG 16X32
• 00643169679962: SPACER 5001532 CONTROL PTC 6 DEG 15X32
• 00643169679955: SPACER 5001432 CONTROL PTC 6 DEG 14X32
• 00643169679948: SPACER 5001332 CONTROL PTC 6 DEG 13X32
• 00643169679931: SPACER 5001232 CONTROL PTC 6 DEG 12X32
• 00643169679924: SPACER 5001132 CONTROL PTC 6 DEG 11X32
• 00643169679917: SPACER 5001827 CONTROL PTC 6 DEG 18X27
• 00643169679900: SPACER 5001727 CONTROL PTC 6 DEG 17X27
• 00643169679894: SPACER 5001627 CONTROL PTC 6 DEG 16X27
• 00643169679887: SPACER 5001527 CONTROL PTC 6 DEG 15X27
• 00643169679870: SPACER 5001427 CONTROL PTC 6 DEG 14X27
• 00643169679863: SPACER 5001327 CONTROL PTC 6 DEG 13X27
• 00643169679856: SPACER 5001227 CONTROL PTC 6 DEG 12X27
• 00643169679849: SPACER 5001127 CONTROL PTC 6 DEG 11X27
• 00643169679832: SPACER 5001027 CONTROL PTC 6 DEG 10X27
• 00643169679825: SPACER 5001822 CONTROL PTC 6 DEG 18X22
• 00643169679818: SPACER 5001722 CONTROL PTC 6 DEG 17X22
• 00643169679801: SPACER 5001622 CONTROL PTC 6 DEG 16X22
• 00643169679795: SPACER 5001522 CONTROL PTC 6 DEG 15X22
• 00643169679788: SPACER 5001422 CONTROL PTC 6 DEG 14X22
• 00643169679771: SPACER 5001322 CONTROL PTC 6 DEG 13X22
• 00643169679764: SPACER 5001222 CONTROL PTC 6 DEG 12X22
• 00643169679757: SPACER 5001122 CONTROL PTC 6 DEG 11X22
• 00643169679740: SPACER 5001022 CONTROL PTC 6 DEG 10X22
• 00643169679733: SPACER 4991832 CONTROL PTC 0 DEG 18X32
• 00643169679726: SPACER 4991732 CONTROL PTC 0 DEG 17X32
• 00643169679719: SPACER 4991632 CONTROL PTC 0 DEG 16X32
• 00643169679702: SPACER 4991532 CONTROL PTC 0 DEG 15X32
• 00643169679696: SPACER 4991432 CONTROL PTC 0 DEG 14X32
• 00643169679689: SPACER 4991332 CONTROL PTC 0 DEG 13X32
• 00643169679672: SPACER 4991232 CONTROL PTC 0 DEG 12X32
• 00643169679665: SPACER 4991132 CONTROL PTC 0 DEG 11X32
• 00643169679658: SPACER 4991032 CONTROL PTC 0 DEG 10X32
• 00643169679641: SPACER 4991827 CONTROL PTC 0 DEG 18X27
• 00643169679634: SPACER 4991727 CONTROL PTC 0 DEG 17X27
• 00643169679627: SPACER 4991627 CONTROL PTC 0 DEG 16X27
• 00643169679610: SPACER 4991527 CONTROL PTC 0 DEG 15X27
• 00643169679603: SPACER 4991427 CONTROL PTC 0 DEG 14X27
• 00643169679597: SPACER 4991327 CONTROL PTC 0 DEG 13X27
• 00643169679580: SPACER 4991227 CONTROL PTC 0 DEG 12X27
• 00643169679573: SPACER 4991127 CONTROL PTC 0 DEG 11X27
• 00643169679566: SPACER 4991027 CONTROL PTC 0 DEG 10X27
• 00643169679559: SPACER 4990927 CONTROL PTC 0 DEG 9X27
• 00643169679542: SPACER 4990827 CONTROL PTC 0 DEG 8X27
• 00643169679535: SPACER 4991822 CONTROL PTC 0 DEG 18X22
• 00643169679528: SPACER 4991722 CONTROL PTC 0 DEG 17X22
• 00643169679511: SPACER 4991622 CONTROL PTC 0 DEG 16X22
• 00643169679504: SPACER 4991522 CONTROL PTC 0 DEG 15X22