BLUSTONE SYNERGY, LLC

Address:5520 Ventana Ct,Pueblo,CO,81005,US

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Device Description : The Blustone Synergy Cervical Interbody Fusion System is implanted using a combi 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 trials are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.

Device Class : 1

Duns Number: 033467608

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

Device Description : The Blustone Synergy Cervical Interbody Fusion System is implanted using a combi 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 trials are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.

Device Class : 1

Duns Number: 033467608

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

Device Description : The Blustone Synergy Cervical Interbody Fusion System is implanted using a combi 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 trials are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.

Device Class : 1

Duns Number: 033467608

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

Device Description : The Blustone Synergy Cervical Interbody Fusion System is implanted using a combi 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 trials are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.

Device Class : 1

Duns Number: 033467608

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

Device Description : The Blustone Synergy Cervical Interbody Fusion System is implanted using a combi 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 trials are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.

Device Class : 1

Duns Number: 033467608

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

Device Description : The Blustone Synergy Cervical Interbody Fusion System is implanted using a combi 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 trials are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.

Device Class : 1

Duns Number: 033467608

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

Device Description : The BluStone Synergy Obsidian System is implanted using a combination of device 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.

Device Class : 1

Duns Number: 033467608

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

Device Description : The BluStone Synergy Basalt System is implanted using a combination of device sp 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.

Device Class : 1

Duns Number: 033467608

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1

Device Description : The BluStone Synergy Basalt System is implanted using a combination of device sp 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 Pusher is 8.35 inches long.

Device Class : 1

Duns Number: 033467608

Premarket Exempt : No

Product Code : HXO

Prescription Use : Yes

Device Count : 1

Device Description : The Blustone Synergy Magma System is implanted using a combination of device spe The Blustone Synergy Magma 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 Magma lateral implant inserter is designed to allow for disassembly during cleaning and sterilization.Instructions regarding disassembly, cleaning and sterilization of the inserter instrument are provided in the product insert.

Device Class : 1

Duns Number: 033467608

Premarket Exempt : No

Product Code : FZX

Prescription Use : Yes

Device Count : 1