CD HORIZON® SOLERA® Spinal System

GUDID 00643169490963

ROD 641000030 30MM PERC ROD 4.75MM CCM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00643169490963
NIH Device Record Key7fd03148-e99b-4456-bb81-0881c76aec3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD HORIZON® SOLERA® Spinal System
Version Model Number641000030
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169490963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169490963]

Moist Heat or Steam Sterilization

[00643169490963]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-16

On-Brand Devices [CD HORIZON® SOLERA® Spinal System]

00643169976566ROD X0415073 DUAL BEND 6.0 CCM PLS X 490
00643169976559ROD X0415072 DUAL BEND 6.0 CCM PLS L 400
00643169976542ROD X0415071 DUAL BEND 6.0 CCM PLS S 350
00643169841529TRANS HOOK X0516107 30 DEG-NRW-SML-L
00643169841512TRANS HOOK X0516106 30 DEG-NRW-SML-R
00643169841505TRANS HOOK X0516105 30 DEG-NRW-MED-L
00643169841499TRANS HOOK X0516104 30 DEG-NRW-MED-R
00643169841482TRANS HOOK X0516103 30 DEG-NRW-LRG-L
00643169841475TRANS HOOK X0516102 30 DEG-NRW-LRG-R
00643169841468TRANS HOOK X0516101 45 DEG-NRW-SML-L
00643169841451TRANS HOOK X0516100 45 DEG-NRW-SML-R
00643169841444TRANS HOOK X0516099 45 DEG-NRW-MED-L
00643169841437TRANS HOOK X0516098 45 DEG-NRW-MED-R
00643169841420TRANS HOOK X0516097 45 DEG-NRW-LRG-L
00643169841413TRANS HOOK X0516096 45 DEG-NRW-LRG-R
00643169841406TRANS HOOK X0516095 30 DEG-WIDE-SML-L
00643169841390TRANS HOOK X0516094 30 DEG-WIDE-SML-R
00643169841383TRANS HOOK X0516093 30 DEG-WIDE-MED-L
00643169841376TRANS HOOK X0516092 30 DEG-WIDE-MED-R
00643169841369TRANS HOOK X0516091 30 DEG-WIDE-LRG-L
00643169841352TRANS HOOK X0516090 30 DEG-WIDE-LRG-R
00643169841345TRANS HOOK X0516048 45 DEG-WIDE-SML-L
00643169841338TRANS HOOK X0516047 45 DEG-WIDE-SML-R
00643169841321TRANS HOOK X0516046 45 DEG-WIDE-MED-L
00643169841314TRANS HOOK X0516045 45 DEG-WIDE-MED-R
00643169841307TRANS HOOK X0316003 45 DEG-WIDE-LRG-L
00643169841291TRANS HOOK X0316002 45 DEG-WIDE-LRG-R
00643169834309SCREW 55840047560 5.5SOLERAMAS-ATS7.5X60
00643169834293SCREW 55840047555 5.5SOLERAMAS-ATS7.5X55
00643169834286SCREW 55840047550 5.5SOLERAMAS-ATS7.5X50
00643169834279SCREW 55840047545 5.5SOLERAMAS-ATS7.5X45
00643169834262SCREW 55840047540 5.5SOLERAMAS-ATS7.5X40
00643169834255SCREW 55840047535 5.5SOLERAMAS-ATS7.5X35
00643169834248SCREW 55840047530 5.5SOLERAMAS-ATS7.5X30
00643169834231SCREW 55840047525 5.5SOLERAMAS-ATS7.5X25
00643169834224SCREW 55840047520 5.5SOLERAMAS-ATS7.5X20
00643169834217SCREW 55840046560 5.5SOLERAMAS-ATS6.5X60
00643169834200SCREW 55840046555 5.5SOLERAMAS-ATS6.5X55
00643169834194SCREW 55840046550 5.5SOLERAMAS-ATS6.5X50
00643169834187SCREW 55840046545 5.5SOLERAMAS-ATS6.5X45
00643169834170SCREW 55840046540 5.5SOLERAMAS-ATS6.5X40
00643169834163SCREW 55840046535 5.5SOLERAMAS-ATS6.5X35
00643169834156SCREW 55840046530 5.5SOLERAMAS-ATS6.5X30
00643169834149SCREW 55840046525 5.5SOLERAMAS-ATS6.5X25
00643169834132SCREW 55840046520 5.5SOLERAMAS-ATS6.5X20
00643169834125SCREW 55840045560 5.5SOLERAMAS-ATS5.5X60
00643169834118SCREW 55840045555 5.5SOLERAMAS-ATS5.5X55
00643169834101SCREW 55840045550 5.5SOLERAMAS-ATS5.5X50
00643169834095SCREW 55840045545 5.5SOLERAMAS-ATS5.5X45
00643169834088SCREW 55840045540 5.5SOLERAMAS-ATS5.5X40

Trademark Results [CD HORIZON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CD HORIZON
CD HORIZON
75079759 2108361 Live/Registered
WARSAW ORTHOPEDIC, INC.
1996-03-28
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