SPINENET ACC ®

GUDID B047CINS1100

SpineNet ACC® Inserter Assembly-Instrument

SPINENET, LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: B047CINS1100
• NIH Device Record Key: d1c9290d-e7f5-48ff-8d8a-51eb1b12a37f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPINENET ACC ®
• Version Model Number: CINS1100
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B047CINS1100 [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

[B047CINS1100]

Moist Heat or Steam Sterilization

[B047CINS1100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-10

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