Blustone Synergy Cervical Interbody Fusion System (Slate)

GUDID 00810482030347

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.

BLUSTONE SYNERGY, LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID00810482030347
NIH Device Record Keya083c1ae-2ac0-47b2-952c-68b73b8d8b15
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlustone Synergy Cervical Interbody Fusion System (Slate)
Version Model Number1713-CL09
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

Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810482030347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810482030347]

Moist Heat or Steam Sterilization


[00810482030347]

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 Cervical Interbody Fusion System (Slate)]

00810482030361The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030354The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030347The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030330The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030323The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030316The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030309The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030071The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030064The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030057The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030040The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030033The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030026The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an
00810482030019The Blustone Synergy Slate System is a cervical interbody fusion system comprised of parallel an

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