blustonesynergy.comBlustone Synergy Diamond SA Cervical System
Blustone Synergy, LLC
BLUSTONE SYNERGY, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014019090 | 3014019090 | BLUSTONE SYNERGY, LLC | 1 | N | 2026-01-01 | 5520 Ventana Ct Pueblo CO US 81005 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810482030637 | Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach. | 800-232-9108 | admin@blustonesynergy.com |
| 00810482030644 | Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach. | 800-232-9108 | admin@blustonesynergy.com |
| 00810482030651 | Blustone Synergy Cervical Inserter - 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. | 8002329108 | admin@blustonesynergy.com |
| 00810482030668 | Blustone Synergy Cervical Pusher - 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. | 8002329108 | admin@blustonesynergy.com |
| 00810482031382 | Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian) - 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. | 800-232-9108 | admin@blustonesynergy.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 211419 | 1397456932 | K172330 | Blustone Synergy Silica System | MQP | 2017-12-21 |
| 211419 | 1600281752 | K171893 | Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) | MAX | 2017-09-08 |
| 211419 | 1002783682 | ||||
| 211419 | 1197152215 | ||||
| 211419 | 1427096556 | ||||
| 211419 | 1441802040 | ||||
| 211419 | 1930837470 |
Product Codes Associated With Registrations#
PMN#
Blustone Synergy Interbody Fusion System
Blustone Synergy, LLC
Blustone Synergy Silica System
Blustone Synergy
GUDID#
Blustone Synergy Lumbar Lateral Inserter (Magma) - 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.
2018-01-29
Blustone Synergy Lumbar PLIF Inserter (Basalt) - 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.
2018-01-29
Blustone Synergy Lumbar TLIF Inserter/Pusher (Obsidian) - 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.
2018-01-29
Blustone Synergy Cervical Inserter - 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.
2018-01-29
Blustone Synergy Lumbar PLIF Pusher (Basalt) - 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.
2018-01-29
Blustone Synergy Cervical Pusher - 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.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Magma) - The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Obsidian) - The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via a transforaminal (TLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Obsidian) - The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via a transforaminal (TLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Obsidian) - The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via a transforaminal (TLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Obsidian) - The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via a transforaminal (TLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Obsidian) - The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via a transforaminal (TLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Obsidian) - The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via a transforaminal (TLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Obsidian) - The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via a transforaminal (TLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Basalt) - The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted:- bi-laterally in pairs via a posterior (PLIF) approach; or- as a single device via a transverse (T-PLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Basalt) - The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted:- bi-laterally in pairs via a posterior (PLIF) approach;or,- as a single device via a transverse (T-PLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Basalt) - The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted:- bi-laterally in pairs via a posterior (PLIF) approach; or- as a single device via a transverse (T-PLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Basalt) - The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted:- bi-laterally in pairs via a posterior (PLIF) approach; or- as a single device via a transverse (T-PLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Basalt) - The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted:- bi-laterally in pairs via a posterior (PLIF) approach; or- as a single device via a transverse (T-PLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Basalt) - The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted:- bi-laterally in pairs via a posterior (PLIF) approach; or- as a single device via a transverse (T-PLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Basalt) - The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted:- bi-laterally in pairs via a posterior (PLIF) approach;or- as a single device via a transverse (T-PLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Basalt) - The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted:- bi-laterally in pairs via a posterior (PLIF) approach; or- as a single device via a transverse (T-PLIF) approach.
2018-01-29
Blustone Synergy Lumbar Interbody Fusion System (Basalt) - .The Blustone Synergy Lumbar Interbody Fusion System (Basalt) may be implanted:- bi-laterally in pairs via a posterior (PLIF) approach; or - as a single device via a transverse (T-PLIF) approach.
2018-01-29
Blustone Synergy Cervical Interbody Fusion System (Slate) - The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.
2018-01-29
Blustone Synergy Cervical Interbody Fusion System (Slate) - The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.
2018-01-29
Blustone Synergy Cervical Interbody Fusion System (Slate) - The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.
2018-01-29
Blustone Synergy Cervical Interbody Fusion System (Slate) - The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.
2018-01-29
Blustone Synergy Cervical Interbody Fusion System (Slate) - The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.
2018-01-29
Blustone Synergy Cervical Interbody Fusion System (Slate) - The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.
2018-01-29