Lumbar Interbody Fusion System (OLLIF) Implant 01-2712

GUDID 00850014575090

Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 27 x 12 mm

ADVANCED RESEARCH MEDICAL LLC

Metallic spinal fusion cage, non-sterile Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID00850014575090
NIH Device Record Key6213dd7d-0ad3-4acf-982e-c76ff0440603
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumbar Interbody Fusion System (OLLIF) Implant
Version Model Number01-2712
Catalog Number01-2712
Company DUNS117201206
Company NameADVANCED RESEARCH MEDICAL 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com
Phone6124401865
Emailinfo@advresmed.com

Device Dimensions

Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter
Height12 Millimeter
Length27 Millimeter
Width9.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014575090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


[00850014575090]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-24
Device Publish Date2019-12-16

On-Brand Devices [Lumbar Interbody Fusion System (OLLIF) Implant]

00850014575069Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 27 x 9 mm
00850014575007Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 27 x 8 mm
00850014575298Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 33 x 8 mm
00850014575281Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 33 x 9 mm
00850014575274Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 33 x 10 mm
00850014575267Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 33 x 11 mm
00850014575250Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 33 x 12 mm
00850014575243Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 33 x 13 mm
00850014575236Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 33 x 14 mm
00850014575229Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 33 x 15 mm
00850014575212Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 30 x 15 mm
00850014575205Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 30 x 14 mm
00850014575199Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 30 x 13 mm
00850014575182Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 30 x 12 mm
00850014575175Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 30 x 11 mm
00850014575168Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 30 x 10 mm
00850014575151Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 30 x 9 mm
00850014575144Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 30 x 8 mm
00850014575120Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 27 x 15 mm
00850014575113Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 27 x 14 mm
00850014575106Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 27 x 13 mm
00850014575090Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 27 x 12 mm
00850014575083Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 27 x 11 mm
00850014575076Lumbar Interbody Fusion System (OLLIF) Oblique Implant 9.5 x 27 x 10 mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.