Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)

GUDID 00840996137348

PLI,BOX CHISEL,12

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996137348
NIH Device Record Keyf9cd6c51-6732-4213-96cb-e53cff8af83d
Commercial Distribution StatusIn Commercial Distribution
Brand NameChoice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)
Version Model NumberP070-6027
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996137348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996137348]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-07-29

On-Brand Devices [Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™)]

00840996171144PLI,PARALLEL,PADDLE,SHAVER,7X3.25
00840996147897SPCL,DISTRACTOR,18
00840996147880SPCL,DISTRACTOR,17
00840996147873SPCL,DISTRACTOR,16
00840996147866SPCL,DISTRACTOR,15
00840996147859SPCL,DISTRACTOR,13
00840996147842SPCL,DISTRACTOR,12
00840996147835SPCL,DISTRACTOR,11
00840996147828SPCL,DISTRACTOR,10
00840996147811SPCL,DISTRACTOR,9
00840996147804SPCL,DISTRACTOR,8
00840996147798SPCL,DISTRACTOR,7
00840996147781PLI,SPCL,CURETTE,ANGLED,UP
00840996147774PLI,SPCL,CURETTE,ANGLED,DOWN
00840996147767PLI,SPCL,RASP,DOUBLE SIDED,12MM
00840996147750PLI,SPCL,PADDLE SHAVER, PARALLEL,18H
00840996147743PLI,SPCL,PADDLE SHAVER, PARALLEL,17H
00840996147736PLI,SPCL,PADDLE SHAVER, PARALLEL,16H
00840996147729PLI,SPCL,PADDLE SHAVER, PARALLEL,15H
00840996147712PLI,SPCL,PADDLE SHAVER, PARALLEL,14H
00840996147705PLI,SPCL,PADDLE SHAVER, PARALLEL,13H
00840996147699PLI,SPCL,PADDLE SHAVER, PARALLEL,12H
00840996147682PLI,SPCL,PADDLE SHAVER, PARALLEL,11H
00840996147675PLI,SPCL,PADDLE SHAVER, PARALLEL,10H
00840996147668PLI,SPCL,PADDLE SHAVER, PARALLEL,9H
00840996147651PLI,SPCL,PADDLE SHAVER, PARALLEL,8H
00840996147644PLI,SPCL,PADDLE SHAVER, PARALLEL,7H
00840996147637PLI,SPCL,TRIAL,8mmH
00840996147620PLI,SPCL,TRIAL,7H
00840996147613PLI,SPCL, TAMP, ANGLED, 9mmW
00840996147606PLI,SPCL,TAMP, 9mm W
00840996147590PLI,SPCL,TAMP, ANGLED,10.5mm
00840996147583PLI,SPCL,TAMP, 10.5mm
00840996147576SPCL,PLI,BONE GRAFT FUNNEL,NO WINDOWS
00840996147569SPCL,PLI,INSERTER
00840996147552PLI, SPECIAL TAMP
00840996147545SPCL,HARPOON,TAMP W/ ARM
00840996147538SPCL,HARPOON,TAMP W/ TEETH
00840996147521PLI,SPCL,CURETTE,ANGLED
00840996147514PLI,SPCL,CURETTE,STRAIGHT
00840996147507PLI,SPCL,RASP,ANGLED
00840996147491PLI,SPCL,RASP,STRAIGHT
00840996147484#2 CURETTE, ANGLED, SPECIAL
00840996147477SPCL,PLI,BONE PLUNGER,SHORT
00840996147460SPCL,PLI,BONE PLUNGER,LONG
00840996147453NERVE ROOT RETRACTOR, SPECIAL
00840996147446SPCL,PLI,SLAP HAMMER
00840996147439SPCL,PLI,INSERTER
00840996147422SPCL,PLI,MUTLITOOL
00840996147415SPCL,BONE GRAFT PLUNGER

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