Avenue L IR90084R

GUDID 03662663033381

TRIAL H10MM 17X60MM 0°

LDR Spine Usa, Inc.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial
Primary Device ID03662663033381
NIH Device Record Key537f99c8-efbc-48df-91d7-1b2598e1f6ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvenue L
Version Model NumberIR90084R
Catalog NumberIR90084R
Company DUNS615789729
Company NameLDR Spine Usa, Inc.
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

Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com
Phone800-699-3360
Emailcustserv@ldrspine.com

Device Dimensions

Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter
Angle0 degree
Depth17 Millimeter
Height10 Millimeter
Width60 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS103662663033381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


[03662663033381]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-03-10
Device Publish Date2017-03-22

On-Brand Devices [Avenue L]

03662663039666AVENUE-L REVISION SYSTEM
03662663046671Avenue-L Angled Minimal Holder
03662663046657Avenue L OLIF Cage Holder
03662663046428Angled Avenue L inserter flexible inner threaded rod
03662663046411Angled Avenue L inserter
03662663040259AVENUE L TRIAL IMPLANT HOLDER
03662663039642AVENUE-L ANCH PLATE IMPACTOR
03662663039628AVENUE-L CAGE HOLDER
03662663046176EC990A
03662663046169IR994C
03662663046152IR994B
03662663046145IR994A
03662663036580EC480T
03662663036573EC470T
03662663036566EC460T
03662663036559EC450T
03662663036542EC210T
03662663036535EC200T
03662663036528EC190T
03662663036511EC180T
03662663036504EC170T
03662663036498EC160T
03662663036481EC150T
03662663036474EC140T
03662663036467EC130T
03662663036450EC120T
03662663036443EC110T
03662663036436EC100T
03662663036429EC090T
03662663036412EC021R
03662663036405EC020R
03662663036399EC019R
03662663036375EC017R
03662663036368EC016R
03662663036351EC015R
03662663036344EC014R
03662663046916Avenue-L Trial 22mm H14 10°
03662663046909Avenue-L Trial 22mm H12 10°
03662663046893Avenue-L Trial 22mm H10 10°
03662663046886Avenue-L Trial 22mm H08 10°
03662663046879Avenue-L Trial 22mm H16 6°
03662663046862Avenue-L Trial 22mm H16 0°
03662663046855Avenue-L Trial 22mm H14 6°
03662663046848Avenue-L Trial 22mm H14 0°
03662663046831Avenue-L Trial 22mm H12 6°
03662663046824Avenue-L Trial 22mm H12 0°
03662663046817Avenue-L Trial 22mm H10 6°
03662663046800Avenue-L Trial 22mm H10 0°
03662663046794Avenue-L Trial 22mm H08 6°
03662663046787Avenue-L Trial 22mm H08 0°

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