Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)

GUDID 00810482030163

The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configurations of various heights. The implants are designed with a 15mm x 13mm footprint in heights ranging from 20 to 50mm in three (3) mm increments. The device is hollow to allow for placement of autograft and/or allogenic bone graft and facilitate fusion, and contains tantalum markers to assist the surgeon with proper placement of the device. The device may be implanted as a single device via an anterior approach.

BLUSTONE SYNERGY, LLC

Vertebral body prosthesis

• Primary Device ID: 00810482030163
• NIH Device Record Key: 580e3bc4-da0d-4e9c-9a08-5160d0af135d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)
• Version Model Number: 1513-C044
• 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

• Height: 44 Millimeter
• Height: 44 Millimeter
• Height: 44 Millimeter
• Height: 44 Millimeter
• Height: 44 Millimeter
• Height: 44 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810482030163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172330

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[00810482030163]

Moist Heat or Steam Sterilization

[00810482030163]

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 Spinal Intervertebral Body Fixation System (Silica)]

• 00810482030293: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030286: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030279: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030262: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030255: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030248: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030231: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030224: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030217: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030200: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030194: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030187: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030170: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030163: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030156: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030149: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030132: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030125: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030118: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030101: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030095: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio
• 00810482030088: The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configuratio