Avenue L IR90203R

GUDID 03662663034241

TRIAL H16MM 22X45MM 10°

LDR Spine Usa, Inc.

Spinal implant trial

• Primary Device ID: 03662663034241
• NIH Device Record Key: f0941eff-deaa-4be9-803a-834424eb4673
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avenue L
• Version Model Number: IR90203R
• Catalog Number: IR90203R
• Company DUNS: 615789729
• Company Name: LDR Spine Usa, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com
• Phone: 800-699-3360
• Email: custserv@ldrspine.com

Device Dimensions

• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter
• Angle: 10 degree
• Depth: 22 Millimeter
• Height: 16 Millimeter
• Width: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663034241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153495

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

[03662663034241]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-03-10
• Device Publish Date: 2017-03-23

On-Brand Devices [Avenue L]

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