Blustone Synergy Lumbar Interbody Fusion System (Magma)

GUDID 00810482030590

The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a lateral (LLIF) approach.

BLUSTONE SYNERGY, LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID00810482030590
NIH Device Record Keyd8b1b4c2-1726-4bc1-898e-df2b21152cd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlustone Synergy Lumbar Interbody Fusion System (Magma)
Version Model Number5018-LP08
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

Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter
Length50 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810482030590 [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

[00810482030590]

Moist Heat or Steam Sterilization


[00810482030590]

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 (Magma)]

00810482030644The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030637The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030620The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030613The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030606The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030590The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030583The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030576The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030569The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030552The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030545The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a
00810482030538The Blustone Synergy Lumbar Magma Interbody Fusion System is implanted as a single device via a

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