Blustone Synergy Lumbar Trial/Spreader (Basalt, Obsidian, Magma)

GUDID 00810482030750

The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The lumbar trials/spreaders are available in sizes between 7mm and 15mm.

BLUSTONE SYNERGY, LLC

Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: 00810482030750
• NIH Device Record Key: 91e5e37c-7234-49b1-b7a6-63faa4b43940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blustone Synergy Lumbar Trial/Spreader (Basalt, Obsidian, Magma)
• Version Model Number: 9000-SP14
• 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: 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

Customer Support Contacts

• Phone: 800-232-9108
• Email: admin@blustonesynergy.com
• Phone: 800-232-9108
• Email: admin@blustonesynergy.com

Device Dimensions

• Height: 14 Millimeter
• Height: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810482030750 [Primary]

FDA Product Code

• HWT: Template

Sterilization

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

[00810482030750]

Moist Heat or Steam Sterilization

[00810482030750]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2018-01-29

On-Brand Devices [Blustone Synergy Lumbar Trial/Spreader (Basalt, Obsidian, Magma)]

• 00810482030767: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device s
• 00810482030750: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device s
• 00810482030743: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device s
• 00810482030736: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device s
• 00810482030729: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device s
• 00810482030712: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device s
• 00810482030705: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device s
• 00810482030699: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device s
• 00810482030675: The Blustone Synergy Lumbar Interbody Fusion System is implanted using a combination of device s