Capstone Control PTC Spinal System

GUDID 00643169677593

SPACER 5011227 CONTROL PTC 12 DEG 12X27

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile

Primary Device ID	00643169677593
NIH Device Record Key	af318e4f-2af6-4d62-ac8a-7dded12c981d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Capstone Control PTC Spinal System
Version Model Number	5011227
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

Device Dimensions

Length	27 Millimeter
Length	27 Millimeter
Length	27 Millimeter
Length	27 Millimeter
Length	27 Millimeter
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter
Height	12 Millimeter
Angle	12 degree
Length	27 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169677593 [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