Blustone Synergy Lumbar Interbody Fusion System (Obsidian)

GUDID 00810482030460

The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via a transforaminal (TLIF) approach.

BLUSTONE SYNERGY, LLC

Polymeric spinal interbody fusion cage
Primary Device ID00810482030460
NIH Device Record Keyce1ff6a4-e773-4ef5-9f5d-7a0858d248cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlustone Synergy Lumbar Interbody Fusion System (Obsidian)
Version Model Number2811-TL08
Company DUNS033467608
Company NameBLUSTONE SYNERGY, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-232-9108
Emailadmin@blustonesynergy.com
Phone800-232-9108
Emailadmin@blustonesynergy.com

Device Dimensions

Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810482030460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810482030460]

Moist Heat or Steam Sterilization


[00810482030460]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2018-01-29

On-Brand Devices [Blustone Synergy Lumbar Interbody Fusion System (Obsidian)]

00810482030521The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
00810482030514The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
00810482030507The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
00810482030491The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
00810482030484The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
00810482030477The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via
00810482030460The Blustone Synergy Lumbar Obsidian Interbody Fusion System is implanted as a single device via

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