Capstone Control PTC Spinal System

GUDID 00643169679634

SPACER 4991727 CONTROL PTC 0 DEG 17X27

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile
Primary Device ID00643169679634
NIH Device Record Key234b6614-3d27-492b-a45a-8ff6f21f759c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapstone Control PTC Spinal System
Version Model Number4991727
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Angle0 degree
Angle0 degree
Angle0 degree
Angle0 degree
Angle0 degree
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree
Length27 Millimeter
Height17 Millimeter
Angle0 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169679634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-02
Device Publish Date2018-09-01

On-Brand Devices [Capstone Control PTC Spinal System]

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