Blustone Synergy Lumbar Interbody Fusion System (Obsidian)

GUDID 00810482030491

The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via a transforaminal (TLIF) approach.

BLUSTONE SYNERGY, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: 00810482030491
• NIH Device Record Key: 522d67f4-d67c-46a5-be3f-6f50a2aa73bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blustone Synergy Lumbar Interbody Fusion System (Obsidian)
• Version Model Number: 2811-TL11
• Company DUNS: 033467608
• Company Name: BLUSTONE SYNERGY, 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: 800-232-9108
• Email: admin@blustonesynergy.com
• Phone: 800-232-9108
• Email: admin@blustonesynergy.com

Device Dimensions

• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810482030491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171893

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00810482030491]

Moist Heat or Steam Sterilization

[00810482030491]

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: 2018-01-29

On-Brand Devices [Blustone Synergy Lumbar Interbody Fusion System (Obsidian)]

• 00810482030521: The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
• 00810482030514: The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
• 00810482030507: The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
• 00810482030491: The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
• 00810482030484: The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
• 00810482030477: The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
• 00810482030460: The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via