Arristos

GUDID 00843672100063

Polyax screw 5.5x30mm for 5.5 rod

INGENIUMSPINE, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00843672100063
NIH Device Record Key61d9f65d-8966-4c5f-9969-c44e740bd1c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameArristos
Version Model Number55015530
Company DUNS082805471
Company NameINGENIUMSPINE, LLC
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843672100063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843672100063]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-11
Device Publish Date2018-06-15

On-Brand Devices [Arristos]

00084372100216Polyax screw 6.5x45mm for 5.5 rod
00084372100070Polyax screw 5.5x35mm for 5.5 rod
00084372100063Polyax screw 5.5x30mm for 5.5 rod
00083672101565Rod Approximator
00843672101589Hook Approximator 5.0 Rod
00843672101572Hook Approximator 6.0mm Rod
00843672101558Tap for 7.5mm Screw
00843672101541Tap for 6.5mm Screw
00843672101534Tap for 7.0mm Screw
00843672101527Tap for 6.0mm Screw
00843672101510Tap for 5.5mm Screw
0084367210150356010017
00843672101497Center plug T-20 M6xH3mm
00843672101480Transverse plug T-20 M6xH4mm
00843672101473Buttress plug M10 T25 hooks
00843672101466Buttress plug M8 T25 hooks
00843672101459Smooth rod 6x500mm Ti
00843672101442Smooth rod 6x500mm CrCo
00843672101435Smooth rod 6x450mm
00843672101428Smooth rod 6x300mm
00843672101411Smooth rod 6x200mm
00843672101404Smooth rod 6x180mm
00843672101398Smooth rod 6x150mm
00843672101381Smooth rod 6x120mm
00843672101374Smooth rod 6x100mm
00843672101367Smooth rod 6x90mm
00843672101350Smooth rod 6x80mm
00843672101343Smooth rod 6x70mm
00843672101336Smooth rod 6x60mm
00843672101329Smooth rod 6x50mm
00843672101312Smooth rod 6x40mm
00843672101305Transverse 6.0mm/71-115mm
00843672101299Transverse 6.0mm/49-71mm
00843672101282Transverse 6.0mm/38-49mm
00843672101275Transverse 6.0mm/33-38mm
00843672101268Transverse 6.0mm/30-33mm
00843672101251Transverse 6.0mm/27-30mm
00843672101244Polyax screw 7.5x55mm for 6.0 rod
00843672101237Polyax screw 7.5x50mm for 6.0 rod
00843672101220Polyax screw 7.5x45mm for 6.0 rod
00843672101213Polyax screw 7.5x40mm for 6.0 rod
00843672101206Polyax screw 6.5x55mm for 6.0 rod
00843672101190Polyax screw 6.5x50mm for 6.0 rod
00843672101183Polyax screw 6.5x45mm for 6.0 rod
00843672101176Polyax screw 6.5x40mm for 6.0 rod
00843672101169Polyax screw 6.5x35mm for 6.0 rod
00843672101152Polyax screw 6.5x30mm for 6.0 rod
00843672101145Polyax screw 5.5x55mm for 6.0 rod
00843672101138Polyax screw 5.5x50mm for 6.0 rod
00843672101121Polyax screw 5.5x45mm for 6.0 rod

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