Blustone Synergy Lumbar Interbody Fusion System (Basalt)

GUDID 00810482030453

The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in pairs via a posterior (PLIF) approach; or - as a single device via a transverse (T-PLIF) approach.

BLUSTONE SYNERGY, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: 00810482030453
• NIH Device Record Key: 5ca0f480-1ddc-427c-80fb-8ed7366a069d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blustone Synergy Lumbar Interbody Fusion System (Basalt)
• Version Model Number: 2410-PP09
• 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: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com

Device Dimensions

• Length: 24 Millimeter
• Length: 24 Millimeter
• Length: 24 Millimeter
• Length: 24 Millimeter
• Length: 24 Millimeter
• Length: 24 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810482030453 [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

[00810482030453]

Moist Heat or Steam Sterilization

[00810482030453]

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 (Basalt)]

• 00810482030453: The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in
• 00810482030446: The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in
• 00810482030439: The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in
• 00810482030422: The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in
• 00810482030415: The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in
• 00810482030408: The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in
• 00810482030392: The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in
• 00810482030385: The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally in
• 00810482030378: .The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted: - bi-laterally i