Blustone Synergy Cervical Inserter

GUDID 00810482030651

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 implant inserter is designed to allow for disassembly during cleaning and sterilization.Instructions regarding disassembly of the inserter instrument are provided in the product insert.

BLUSTONE SYNERGY, LLC

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00810482030651
• NIH Device Record Key: e0e79527-e2e6-4cff-a7b3-a9bdb2e4c2cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blustone Synergy Cervical Inserter
• Version Model Number: 9000-CI01
• 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: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com
• Phone: 8002329108
• Email: admin@blustonesynergy.com

Device Dimensions

• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch
• Length: 6.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810482030651 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

[00810482030651]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-01-29

Devices Manufactured by BLUSTONE SYNERGY, LLC

• 00810482030019 - Blustone Synergy Cervical Interbody Fusion System (Slate): 2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
• 00810482030026 - Blustone Synergy Cervical Interbody Fusion System (Slate): 2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
• 00810482030033 - Blustone Synergy Cervical Interbody Fusion System (Slate): 2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
• 00810482030040 - Blustone Synergy Cervical Interbody Fusion System (Slate): 2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
• 00810482030057 - Blustone Synergy Cervical Interbody Fusion System (Slate): 2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
• 00810482030064 - Blustone Synergy Cervical Interbody Fusion System (Slate): 2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
• 00810482030071 - Blustone Synergy Cervical Interbody Fusion System (Slate): 2020-02-24 The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two foot
• 00810482030088 - Blustone Synergy Spinal Intervertebral Body Fixation System (Silica): 2020-02-24 The Silica implants are rectangular shaped blocks in parallel, 3° and 6° lordotic configurations of various heights. The impl