Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian)

GUDID 00810482031382

The BluStone Synergy Obsidian 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 Obsidian TLIF implant inserter/pusher is designed to allow for disassembly during cleaning and sterilization. Instructions regarding disassembly, cleaning and sterilization of the inserter/pusher instrument are provided in the product insert.

BLUSTONE SYNERGY, LLC

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00810482031382
• NIH Device Record Key: c3213c5f-e825-4600-8c0e-96a9d96b3829
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian)
• Version Model Number: 9100-TI01
• 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

• Lumen/Inner Diameter: 0.218 Inch
• Lumen/Inner Diameter: 0.218 Inch
• Lumen/Inner Diameter: 0.218 Inch
• Lumen/Inner Diameter: 0.218 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810482031382 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810482031382]

Moist Heat or Steam Sterilization

[00810482031382]

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

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• 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
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