SPINENET ACC ®

GUDID B047CL1012050

10mmx12mmx5mm

SPINENET, LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: B047CL1012050
• NIH Device Record Key: e18ac2d3-31e6-427a-9bca-cc9db457e27c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPINENET ACC ®
• Version Model Number: CL101205
• 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: 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

Device Dimensions

• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter
• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B047CL1012050 [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

[B047CL1012050]

Moist Heat or Steam Sterilization

[B047CL1012050]

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: 2015-10-05

On-Brand Devices [SPINENET ACC ®]

• B047CTRC1400: SPINENET ACC ® -Transportation Case
• B047CL1012050: 10mmx12mmx5mm
• B047CINS1100: SpineNet ACC® Inserter Assembly-Instrument
• B047CGRP1300: SPINENET ACC ® Graft Pusher-Instrument
• B047CGRB1200: SPINENET ACC ® Graft Block-Instrument