Aries Lumbar Interbody System 1150-7010

GUDID B06211507010

10" Bone Funnel

Osseus Fusion Systems, LLC

Bone graft funnel Bone graft funnel Bone graft funnel Bone graft funnel
Primary Device IDB06211507010
NIH Device Record Key0c84885c-6340-48a1-9070-b2b1eaf62718
Commercial Distribution StatusIn Commercial Distribution
Brand NameAries Lumbar Interbody System
Version Model Number1150-7010
Catalog Number1150-7010
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
HIBCCB06211507010 [Primary]
HIBCCB06211507010 [Primary]
HIBCCB06211507010 [Primary]
HIBCCB06211507010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B06211507010]

Moist Heat or Steam Sterilization


[B06211507010]

Moist Heat or Steam Sterilization


[B06211507010]

Moist Heat or Steam Sterilization


[B06211507010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

Devices Manufactured by Osseus Fusion Systems, LLC

B06211503000 - Aries-T Lumbar Interbody System2020-05-21 Aries TSLIF Inserter
B06211507010 - Aries Lumbar Interbody System2020-05-2110" Bone Funnel
B06211507010 - Aries Lumbar Interbody System2020-05-21 10" Bone Funnel
B06211507110 - Aries-T Lumbar Interbody System2020-05-21 10" Bone Funnel Impactor
B06214501240 - Aries-L Lateral Lumbar Interbody System2020-05-19 20x60x08, 8 degree LLIF Trial
B06214501241 - Aries-L Lateral Lumbar Interbody System2020-05-19 20x60x10, 8 degree, LLIF Trial
B06214501243 - Aries-L Lateral Lumbar Interbody System2020-05-19 20x60x14, 8 degrees, LLIF Trial
B06214505000 - Aries-L Lateral Lumbar Interbody System2020-05-19 LLIF Inserter
B06214505244 - Aries-L Lateral Lumbar Interbody System2020-05-19 20x60x16, 12 degree trial, LLIF

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