Blustone Synergy Cervical Interbody Fusion System (Slate)

GUDID 00810482030064

The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

BLUSTONE SYNERGY, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: 00810482030064
• NIH Device Record Key: 37ba5a5b-fa7a-4462-ad7e-694dddcd3133
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blustone Synergy Cervical Interbody Fusion System (Slate)
• Version Model Number: 1411-CL10
• 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: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810482030064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171893

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00810482030064]

Moist Heat or Steam Sterilization

[00810482030064]

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 Cervical Interbody Fusion System (Slate)]

• 00810482030361: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030354: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030347: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030330: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030323: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030316: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030309: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030071: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030064: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030057: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030040: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030033: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030026: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
• 00810482030019: The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an