Aries-L Lateral Lumbar Interbody System 1450-1240

GUDID B06214501240

20x60x08, 8 degree LLIF Trial

Osseus Fusion Systems, LLC

Spinal implant trial Spinal implant trial Spinal implant trial
Primary Device IDB06214501240
NIH Device Record Key7fb2683a-9f24-4599-ab0f-a8c1f3b701d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAries-L Lateral Lumbar Interbody System
Version Model Number1450-1240
Catalog Number1450-1240
Company DUNS933442068
Company NameOsseus Fusion Systems, 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 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB06214501240 [Primary]
HIBCCB06214501240 [Primary]
HIBCCB06214501240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B06214501240]

Moist Heat or Steam Sterilization


[B06214501240]

Moist Heat or Steam Sterilization


[B06214501240]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [Aries-L Lateral Lumbar Interbody System]

B0621400122020x50x8, 8 degree, LLIF
B0621400121420x45x16, 8 degree, LLIF
B0621400121320x45x14, 8 degree, LLIF
B0621400121220x45x12, 8 degree, LLIF
B0621400121120x45x10, 8 degree, LLIF
B0621400121020x45x8, 8 degree, LLIF
B0621400120420x40x16, 8 degree, LLIF
B0621400120320x40x14, 8 degree, LLIF
B0621400120220x40x12, 8 degree, LLIF
B0621400120120x40x10, 8 degree, LLIF
B0621400120020x40x8, 8 degree, LLIF
B0621400024420x60x16, 0 degree, LLIF
B0621400024320x60x14, 0 degree, LLIF
B0621400024220x60x12, 0 degree, LLIF
B0621400024120x60x8, 0 degree, LLIF
B0621400024020x60x8, 0 degree, LLIF
B0621400023420x55x16, 0 degree, LLIF
B0621400023320x55x14, 0 degree, LLIF
B0621400023220x55x12, 0 degree, LLIF
B0621400023120x55x10, 0 degree, LLIF
B0621400023020x55x8, 0 degree, LLIF
B0621400022420x50x16, 0 degree, LLIF
B0621400022320x50x14, 0 degree, LLIF
B0621400022214000222
B0621400022120x50x10, 0 degree, LLIF
B0621400022020x50x8, 0 degree, LLIF
B0621400021420x45x16, 0 Degree, LLIF
B0621400021320x45x14, 0 degree, LLIF
B0621400021220x45x12, 0 Degree LLIF
B0621400021120x45x10, 0 degree LLIF
B0621400021020x45x8, 0 degree LLIF
B0621400020420x40x14, 0 degree LLIF
B0621400020320x40x14, 0 degree, LLIF
B062140002021400-0202
B062140002011400-0201
B062140002001400-0200
B0621400522120x50x10, 12 degree, LLIF
B0621400522020x50x8,12 degree, LLIF
B0621400521420x45x16, 12 degree, LLIF
B0621400521320x45x14, 12 degree, LLIF
B0621400521120x45x10, 12 degree, LLIF
B0621400521020x45x8, 12 degree, LLIF
B0621400520420x40x16, 12 degree, LLIF
B0621400520320x40x14, 12 degree, LLIF
B0621400520220x40x12, 12 degree, LLIF
B0621400520120x40x10, 12 degree, LLIF
B0621400520020x40x8, 12 degree, LLIF
B0621400124420x60x16, 8 degree, LLIF
B0621400124320x60x14, 8 degree, LLIF
B0621400124220x60x12, 8 degree, LLIF

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