Blustone Synergy Lumbar Interbody Fusion System (Basalt)

GUDID 00810482030439

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.

BLUSTONE SYNERGY, LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID00810482030439
NIH Device Record Keyfc0129bf-b738-4afb-803d-da4322788cd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlustone Synergy Lumbar Interbody Fusion System (Basalt)
Version Model Number2410-PP07
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

Phone8002329108
Emailadmin@blustonesynergy.com
Phone8002329108
Emailadmin@blustonesynergy.com

Device Dimensions

Length24 Millimeter
Length24 Millimeter
Length24 Millimeter
Length24 Millimeter
Length24 Millimeter
Length24 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810482030439 [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

[00810482030439]

Moist Heat or Steam Sterilization


[00810482030439]

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 (Basalt)]

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