Avenue L IR90503R

GUDID 03662663041218

MEDIUM ANCHORING PLATE STARTER AWL

LDR Spine Usa, Inc.

Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel Orthopaedic chisel

• Primary Device ID: 03662663041218
• NIH Device Record Key: 4a57c373-d72b-4538-9da4-22d4fd4cd2d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avenue L
• Version Model Number: IR90503R
• Catalog Number: IR90503R
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663041218 [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

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

[03662663041218]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-03-10
• Device Publish Date: 2017-03-22

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°