Blustone Synergy Lumbar PLIF Inserter (Basalt)

GUDID 00810482031405

The BluStone Synergy Basalt 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 Basalt PLIF implant inserter 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: 00810482031405
• NIH Device Record Key: d045b578-a9e1-4587-8144-59b6109146f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blustone Synergy Lumbar PLIF Inserter (Basalt)
• Version Model Number: 9200-PI01
• 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: 0.201 Inch
• Lumen/Inner Diameter: 0.201 Inch
• Lumen/Inner Diameter: 0.201 Inch
• Lumen/Inner Diameter: 0.201 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810482031405 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810482031405]

Moist Heat or Steam Sterilization

[00810482031405]

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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