HONOUR™ Spacer System

GUDID 00889929026458

TLIF, EZ, 28x10x16 mm, Parallel

NEXXT SPINE, LLC

Vertebral body prosthesis, non-sterile

• Primary Device ID: 00889929026458
• NIH Device Record Key: d05f29ee-3a56-4d4b-86a1-c5ab1b9635b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HONOUR™ Spacer System
• Version Model Number: 16-2810-16P
• Company DUNS: 003489810
• Company Name: NEXXT SPINE, LLC
• 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: true
• 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: 317-436-7801
• Email: Support@nexxtspine.com

Device Dimensions

• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929026458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120345

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00889929026458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-02-09

On-Brand Devices [HONOUR™ Spacer System]

• 00889929026458: TLIF, EZ, 28x10x16 mm, Parallel
• 00889929026441: TLIF, EZ, 28x10x16 mm, Lordotic
• 00889929025536: TLIF, Lordotic, 36mm L x 10mm W x 17mm H
• 00889929025529: TLIF, Lordotic, 36mm L x 10mm W x 16mm H
• 00889929025512: TLIF, Lordotic, 36mm L x 10mm W x 15mm H
• 00889929025505: TLIF, Lordotic, 36mm L x 10mm W x 14mm H
• 00889929025499: TLIF, Lordotic, 36mm L x 10mm W x 13mm H
• 00889929025482: TLIF, Lordotic, 36mm L x 10mm W x 12mm H
• 00889929025475: TLIF, Lordotic, 36mm L x 10mm W x 11mm H
• 00889929025468: TLIF, Lordotic, 36mm L x 10mm W x 10mm H
• 00889929025451: TLIF, Lordotic, 36mm L x 10mm W x 9mm H
• 00889929025444: TLIF, Lordotic, 36mm L x 10mm W x 8mm H
• 00889929025437: TLIF, Lordotic, 36mm L x 10mm W x 7mm H
• 00889929025420: TLIF, Lordotic, 36mm L x 10mm W x 6mm H
• 00889929025413: TLIF, Parallel, 30mm L x 10mm W x 17mm H
• 00889929025406: TLIF, Parallel, 30mm L x 10mm W x 16mm H
• 00889929025390: TLIF, Lordotic, 30mm L x 10mm W x 17mm H
• 00889929025383: TLIF, Lordotic, 30mm L x 10mm W x 16mm H
• 00889929025376: TLIF, Lordotic, 30mm L x 10mm W x 15mm H
• 00889929025222: Straight Lumbar Spacer, 34mm L x 10mm W x 17mm H
• 00889929025215: Straight Lumbar Spacer, 34mm L x 10mm W x 16mm H
• 00889929025208: Straight Lumbar Spacer, 34mm L x 10mm W x 15mm H
• 00889929025192: Straight Lumbar Spacer, 34mm L x 10mm W x 14mm H
• 00889929025185: Straight Lumbar Spacer, 34mm L x 10mm W x 13mm H
• 00889929025178: Straight Lumbar Spacer, 34mm L x 10mm W x 12mm H
• 00889929025161: Straight Lumbar Spacer, 34mm L x 10mm W x 11mm H
• 00889929025154: Straight Lumbar Spacer, 34mm L x 10mm W x 10mm H
• 00889929025147: Straight Lumbar Spacer, 34mm L x 10mm W x 9mm H
• 00889929025130: Straight Lumbar Spacer, 34mm L x 10mm W x 8mm H
• 00889929025123: Straight Lumbar Spacer, 34mm L x 10mm W x 7mm H
• 00889929025116: Straight Lumbar Spacer, 34mm L x 10mm W x 6mm H
• 00889929025109: Straight Lumbar Spacer, 32mm L x 10mm W x 17mm H
• 00889929025093: Straight Lumbar Spacer, 32mm L x 10mm W x 16mm H
• 00889929025086: Straight Lumbar Spacer, 32mm L x 10mm W x 15mm H
• 00889929025079: Straight Lumbar Spacer, 32mm L x 10mm W x 14mm H
• 00889929025062: Straight Lumbar Spacer, 32mm L x 10mm W x 8mm H
• 00889929025055: Straight Lumbar Spacer, 32mm L x 10mm W x 7mm H
• 00889929025048: Straight Lumbar Spacer, 32mm L x 10mm W x 6mm H
• 00889929025031: TLIF, EZ, 34x10x14 mm, Parallel
• 00889929025024: TLIF, EZ, 34x10x13 mm, Parallel
• 00889929025017: TLIF, EZ, 34x10x12 mm, Parallel
• 00889929025000: TLIF, EZ, 34x10x11 mm, Parallel
• 00889929024997: TLIF, EZ, 34x10x9 mm, Parallel
• 00889929024980: TLIF, EZ, 34x10x8 mm, Parallel
• 00889929024973: TLIF, EZ, 34x10x7 mm, Parallel
• 00889929009727: Cervical PEEK, 10°, 18Wx16Dx18H
• 00889929009710: Cervical PEEK, 10°, 18Wx16Dx17H
• 00889929009703: Cervical PEEK, 10°, 18Wx16Dx16H
• 00889929009697: Cervical PEEK, 10°, 18Wx16Dx15H
• 00889929009680: Cervical PEEK, 10°, 18Wx16Dx14H