Capstone Control Spinal System

GUDID 00643169677876

SPACER 4031322 CONTROL 24 DEG 13X22

MEDTRONIC SOFAMOR DANEK, INC.

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Primary Device ID00643169677876
NIH Device Record Keyc2986154-8735-4ab9-bb53-d18dbcb1b7e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapstone Control Spinal System
Version Model Number4031322
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

Length22 Millimeter
Length22 Millimeter
Length22 Millimeter
Length22 Millimeter
Length22 Millimeter
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter
Height13 Millimeter
Angle24 degree
Length22 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169677876 [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 Spinal System]

00643169677920SPACER 4031822 CONTROL 24 DEG 18X22
00643169677913SPACER 4031722 CONTROL 24 DEG 17X22
00643169677906SPACER 4031622 CONTROL 24 DEG 16X22
00643169677890SPACER 4031522 CONTROL 24 DEG 15X22
00643169677883SPACER 4031422 CONTROL 24 DEG 14X22
00643169677876SPACER 4031322 CONTROL 24 DEG 13X22
00643169674806SPACER 4031527 CONTROL 24 DEG 15X27
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