ORIA XENA® Top Clip System

GUDID 00840996119061

XENA,SCREW,ST,POLYAXIAL,4.5X25

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996119061
NIH Device Record Keya8d55217-52b6-4379-836a-2e1fd0aa6e69
Commercial Distribution StatusIn Commercial Distribution
Brand NameORIA XENA® Top Clip System
Version Model NumberCT10-BP425
Company DUNS078293017
Company NameChoice Spine, LP
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(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Dimensions

Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter
Length25 Millimeter
Outer Diameter4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996119061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

[00840996119061]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [ORIA XENA® Top Clip System]

00840996131865XENA,DRIVER SLEEVE,COLLAPSIBLE
00840996131858XENA,DRIVER,SHORT
00840996131841XENA,ROD PUSHER
00840996131834XENA,AWL
00840996131827XENA,IMPLANT HOLDER
00840996131810XENA,COUNTER TORQUE 3 SIDED
00840996131803XENA,SINGLE CLIP INSERTER
00840996131797UNIV,PEDICLE FEELER
00840996131780XENA,CLIP REMOVER
00840996131773XENA,COUNTERTORQUE
00840996131766XENA,DRIVER SLEEVE,POLYAXIAL
00840996119504XENA,LOCKING CLIP
00840996119498XENA,SCREW,ST,POLYAXIAL,9.5X50
00840996119481XENA,SCREW,ST,POLYAXIAL,9.5X45
00840996119474XENA,SCREW,ST,POLYAXIAL,9.5X40
00840996119467XENA,SCREW,ST,POLYAXIAL,9.5X35
00840996119450XENA,SCREW,ST,POLYAXIAL,9.5X30
00840996119443XENA,SCREW,ST,POLYAXIAL,8.5X65
00840996119436XENA,SCREW,ST,POLYAXIAL,8.5X60
00840996119429XENA,SCREW,ST,POLYAXIAL,8.5X55
00840996119412XENA,SCREW,ST,POLYAXIAL,8.5X50
00840996119405XENA,SCREW,ST,POLYAXIAL,8.5X45
00840996119399XENA,SCREW,ST,POLYAXIAL,8.5X40
00840996119382XENA,SCREW,ST,POLYAXIAL,7.5X80
00840996119375XENA,SCREW,ST,POLYAXIAL,7.5X75
00840996119368XENA,SCREW,ST,POLYAXIAL,7.5X70
00840996119351XENA,SCREW,ST,POLYAXIAL,7.5X65
00840996119344XENA,SCREW,ST,POLYAXIAL,7.5X60
00840996119337XENA,SCREW,ST,POLYAXIAL,7.5X55
00840996119320XENA,SCREW,ST,POLYAXIAL,7.5X50
00840996119313XENA,SCREW,ST,POLYAXIAL,7.5X45
00840996119306XENA,SCREW,ST,POLYAXIAL,7.5X40
00840996119290XENA,SCREW,ST,POLYAXIAL,7.5X35
00840996119283XENA,SCREW,ST,POLYAXIAL,7.5X30
00840996119276XENA,SCREW,ST,POLYAXIAL,7.5X25
00840996119269XENA,SCREW,ST,POLYAXIAL,6.5X65
00840996119252XENA,SCREW,ST,POLYAXIAL,6.5X60
00840996119245XENA,SCREW,ST,POLYAXIAL,6.5X55
00840996119238XENA,SCREW,ST,POLYAXIAL,6.5X50
00840996119221XENA,SCREW,ST,POLYAXIAL,6.5X45
00840996119214XENA,SCREW,ST,POLYAXIAL,6.5X40
00840996119207XENA,SCREW,ST,POLYAXIAL,6.5X35
00840996119191XENA,SCREW,ST,POLYAXIAL,6.5X30
00840996119184XENA,SCREW,ST,POLYAXIAL,5.5X55
00840996119177XENA,SCREW,ST,POLYAXIAL,5.5X50
00840996119160XENA,SCREW,ST,POLYAXIAL,5.5X45
00840996119153XENA,SCREW,ST,POLYAXIAL,5.5X40
00840996119146XENA,SCREW,ST,POLYAXIAL,5.5X35
00840996119139XENA,SCREW,ST,POLYAXIAL,5.5X30
00840996119122XENA,SCREW,ST,POLYAXIAL,4.5X55
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