Proliant Posterior Pedicle Screw & Hook Fixation System

GUDID 00840996180672

PROLIANT,SCREW,POLYAXIAL,8.5X65

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996180672
NIH Device Record Key03f4fcb0-2c09-46c5-a475-6b4261fe6ab3
Commercial Distribution StatusIn Commercial Distribution
Brand NameProliant Posterior Pedicle Screw & Hook Fixation System
Version Model Number05-050-00-8565
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
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996180672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

[00840996180672]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-13
Device Publish Date2023-02-03

On-Brand Devices [Proliant Posterior Pedicle Screw & Hook Fixation System]

00840996173667PROLIANT,DISTRACTOR,SCREW BASED,REWORK
00840996172912PRO,LE, HOOK, OFFSET, RIGHT, LRG
00840996172905PRO,LE, HOOK, OFFSET, LEFT, LRG
00840996172899PRO,LE, HOOK, PEDICLE, LARGE
00840996172882PRO,LE, HOOK, PEDICLE, SMALL
00840996172875PRO,LE, HOOK, LAMINA, NARROW, LG
00840996172868PRO,LE, HOOK, LAMINA, NARROW, SM
00840996172851PRO,LE, CONNECTOR, SIDE BY SIDE
00840996172844PRO,LE, CONNECTOR, R TO R INLINE
00840996172837PRO,LE, CONNECTOR, OFFSET, 100
00840996172820PRO,LE, CONNECTOR, OFFSET, 60
00840996172813PRO,LE, CONNECTOR, OFFSET, 50
00840996172806PRO,LE, CONNECTOR, OFFSET, 40
00840996172790PRO,LE, CONNECTOR, OFFSET, 30
00840996172783PRO,LE, CONNECTOR, OFFSET, 20
00840996172776PRO,LE, ROD, COCR, STRAIGHT, 480
00840996172769PRO,LE, ROD, COCR, STRAIGHT, 300
00840996172752PRO,LE, ROD, COCR, STRAIGHT, 200
00840996172745PRO,LE, ROD, COCR, CURVED, 110
00840996172738PRO,LE, ROD, COCR, CURVED, 100
00840996172721PRO,LE, ROD, COCR, CURVED, 90
00840996172714PRO,LE, ROD, COCR, CURVED, 80
00840996172707PRO,LE, ROD, COCR, CURVED, 75
00840996172691PRO,LE, ROD, COCR, CURVED, 70
00840996172684PRO,LE, ROD, COCR, CURVED, 65
00840996172677PRO,LE, ROD, COCR, CURVED, 60
00840996172660PRO,LE, ROD, COCR, CURVED, 55
00840996172653PRO,LE, ROD, COCR, CURVED, 50
00840996172646PRO,LE, ROD, COCR, CURVED, 45
00840996172639PRO,LE, ROD, COCR, CURVED, 40
00840996172622PROLIANT, SCREW, POLYAXIAL, 8.5 X 110
00840996172615PROLIANT, SCREW, POLYAXIAL, 8.5 X 100
00840996172608PROLIANT, SCREW, POLYAXIAL, 8.5 X 95
00840996172592PRO,LE, SCREW, MONO, 8.5 x 60
00840996172585PRO,LE, SCREW, MONO, 8.5 x 55
00840996172578PRO,LE, SCREW, MONO, 8.5 x 50
00840996172561PRO,LE, SCREW, MONO, 8.5 x 45
00840996172554PRO,LE, SCREW, MONO, 8.5 x 40
00840996172547PRO,LE, SCREW, MONO, 7.5 x 60
00840996172530PRO,LE, SCREW, MONO, 7.5 x 55
00840996172523PRO,LE, SCREW, MONO, 7.5 x 50
00840996172516PRO,LE, SCREW, MONO, 7.5 x 45
00840996172509PRO,LE, SCREW, MONO, 7.5 x 40
00840996172493PRO,LE, SCREW, MONO, 6.5 x 60
00840996172486PRO,LE, SCREW, MONO, 6.5 x 55
00840996172479PRO,LE, SCREW, MONO, 6.5 x 50
00840996172462PRO,LE, SCREW, MONO, 6.5 x 45
00840996172455PRO,LE, SCREW, MONO, 6.5 x 40
00840996172448PRO,LE, SCREW, MONO, 6.5 x 35
00840996172431PRO,LE, SCREW, MONO, 6.5 x 30
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