SPINENET ACC®

GUDID B047CTL1012080

Trial 10mmx12mmx8mm

SPINENET, LLC

Spinal implant trial

• Primary Device ID: B047CTL1012080
• NIH Device Record Key: 5217b753-2511-4dc7-b4bc-914f882008c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPINENET ACC®
• Version Model Number: CTL101208
• Company DUNS: 792052321
• Company Name: SPINENET, 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: 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

Device Dimensions

• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 10 Millimeter
• Height: 8 Millimeter
• Width: 12 Millimeter
• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B047CTL1012080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110733

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B047CTL1012080]

Moist Heat or Steam Sterilization

[B047CTL1012080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-10-07

On-Brand Devices [SPINENET ACC®]

• B047CTL1214100: Trial 12mmx14mmx10mm
• B047CTL1214090: Trial 12mmx14mmx9mm
• B047CTL1214080: Trial 12mmx14mmx8mm
• B047CTL1214070: Trial 12mmx14mmx7mm
• B047CTL1214060: Trial 12mmx14mmx6mm
• B047CTL1214050: Trial 12mmx14mmx5mm
• B047CTL1012100: Trial 10mmx12mmx10mm
• B047CTL1012090: Trial 10mmx12mmx9mm
• B047CTL1012080: Trial 10mmx12mmx8mm
• B047CTL1012070: Trial 10mmx12mmx7mm
• B047CTL1012060: Trial 10mmx12mmx6mm
• B047CTL1012050: Trial 10mmx12mmx5mm
• B047CL1214100: 12mmx14mmx10mm
• B047CL1214090: 12mmx14mmx9mm
• B047CL1214080: 12mmx14mmx8mm
• B047CL1214070: 12mmx14mmx7mm
• B047CL1214060: 12mmx14mmx6mm
• B047CL1214050: 12mmx14mmx5mm
• B047CL1012100: 10mmx12mmx10mm
• B047CL1012090: 10mmx12mmx9mm
• B047CL1012080: 10mmx12mmx8mm
• B047CL1012070: 10mmx12mmx7mm
• B047CL1012060: 10mmx12mmx6mm