Blustone Synergy Cervical Trial (Slate)

GUDID 00810482031054

The Blustone Synergy Cervical 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 cervical trials are available in parallel and lordotic configurations, 14mmX11mm and 17mmX13mm sizes and thicknesses between 5mm and 11mm.

BLUSTONE SYNERGY, LLC

Surgical implant template, reusable

• Primary Device ID: 00810482031054
• NIH Device Record Key: 18bff7e7-c994-4419-8f74-e1022ad92bbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blustone Synergy Cervical Trial (Slate)
• Version Model Number: 9014-CTP5
• 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: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter
• Height: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810482031054 [Primary]

FDA Product Code

• HWT: Template

Sterilization

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

[00810482031054]

Moist Heat or Steam Sterilization

[00810482031054]

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 Cervical Trial (Slate)]

• 00810482031375: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031368: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031351: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031344: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031337: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031320: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031313: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031306: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031290: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031283: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031276: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031269: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031252: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031245: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031092: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031085: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031078: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031061: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031054: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031047: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031030: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031023: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031016: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482031009: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482030996: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482030989: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482030972: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
• 00810482030965: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device