Crescent Spinal System Titanium

GUDID 00613994849359

SPACER 6671225 CRESCENT TI WD 12MMX25MM

MEDTRONIC SOFAMOR DANEK, INC.

Polymeric spinal fusion cage, sterile
Primary Device ID00613994849359
NIH Device Record Keyf1910ebf-7ed2-4ea7-83ac-5c6b5f82411a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrescent Spinal System Titanium
Version Model Number6671225
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Latexfalse
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

Device Dimensions

Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter
Outer Diameter25 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994849359 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-09

On-Brand Devices [Crescent Spinal System Titanium]

00613994907936TRIAL 9501630 16MMX30MM STR
00613994907929TRIAL 9501530 15MMX30MM STR
00613994907912TRIAL 9501430 14MMX30MM STR
00613994907905TRIAL 9501330 13MMX30MM STR
00613994907899TRIAL 9501230 12MMX30MM STR
00613994907882TRIAL 9501130 11MMX30MM STR
00613994907875TRIAL 9501030 10MMX30MM STR
00613994907868TRIAL 9500930 09MMX30MM STR
00613994907851TRIAL 9500830 08MMX30MM STR
00613994907844TRIAL 9500730 07MMX30MM STR
00613994907776TRIAL 9503016 16MMX30MM ANG
00613994907769TRIAL 9503015 15MMX30MM ANG
00613994907752TRIAL 9503014 14MMX30MM ANG
00613994907745TRIAL 9503013 13MMX30MM ANG
00613994907738TRIAL 9503012 12MMX30MM ANG
00613994907721TRIAL 9503011 11MMX30MM ANG
00613994907714TRIAL 9503010 10MMX30MM ANG
00613994907707TRIAL 9503009 09MMX30MM ANG
00613994907691TRIAL 9503008 08MMX30MM ANG
00613994907684TRIAL 9503007 07MMX30MM ANG
00613994898111INSERTER 6660004 SHAFT
00613994880239SPACER X0310662 CRESCENT PK TAPERED 25X7
00613994880222SPACER X0310663 CRESCENT PK TAPERED 25X8
00613994880215SPACER X0310664 CRESCENT PK TAPERED 25X9
00613994880208SPACER X0310665 CRESCENT PK TAPERD 25X10
00613994880192SPACER X0310666 CRESCENT PK TAPERD 25X11
00613994880185SPACER X0310667 CRESCENT PK TAPERD 25X12
00613994880178SPACER X0310668 CRESCENT PK TAPERD 25X13
00613994880161SPACER X0310669 CRESCENT PK TAPERD 25X14
00613994880154SPACER X0310670 CRESCENT PK TAPERD 25X15
00613994880147SPACER X0610001 CRESCENT PK TAPERED 30X7
00613994880130SPACER X0610002 CRESCENT PK TAPERED 30X8
00613994880123SPACER X0610003 CRESCENT PK TAPERED 30X9
00613994880116SPACER X0610004 CRESCENT PK TAPERD 30X10
00613994880109SPACER X0610005 CRESCENT PK TAPERD 30X11
00613994880093SPACER X0610006 CRESCENT PK TAPERD 30X12
00613994880086SPACER X0610007 CRESCENT PK TAPERD 30X13
00613994880079SPACER X0610008 CRESCENT PK TAPERD 30X14
00613994880062SPACER X0610009 CRESCENT PK TAPERD 30X15
00613994849502SPACER 6670725 CRESCENT TI WD 07MMX25MM
00613994849496SPACER 6670730 CRESCENT TI WD 07MMX30MM
00613994849489SPACER 6670736 CRESCENT TI WD 07MMX36MM
00613994849472SPACER 6670825 CRESCENT TI WD 08MMX25MM
00613994849465SPACER 6670830 CRESCENT TI WD 08MMX30MM
00613994849458SPACER 6670836 CRESCENT TI WD 08MMX36MM
00613994849441SPACER 6670925 CRESCENT TI WD 09MMX25MM
00613994849434SPACER 6670930 CRESCENT TI WD 09MMX30MM
00613994849427SPACER 6670936 CRESCENT TI WD 09MMX36MM
00613994849410SPACER 6671025 CRESCENT TI WD 10MMX25MM
00613994849403SPACER 6671030 CRESCENT TI WD 10MMX30MM
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