Blustone Synergy Cervical Trial (Slate)

GUDID 00810482031313

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 trials are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.

BLUSTONE SYNERGY, LLC

Surgical implant template, reusable Surgical implant template, reusable
Primary Device ID00810482031313
NIH Device Record Key2a155238-349f-4969-a190-c24c5894c304
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlustone Synergy Cervical Trial (Slate)
Version Model Number9017-CTP10
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 Usefalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810482031313 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810482031313]

Moist Heat or Steam Sterilization


[00810482031313]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-26
Device Publish Date2018-01-29

On-Brand Devices [Blustone Synergy Cervical Trial (Slate)]

00810482031375The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031368The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031351The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031344The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031337The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031320The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031313The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031306The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031290The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031283The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031276The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031269The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031252The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031245The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031092The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031085The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031078The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031061The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031054The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031047The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031030The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031023The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031016The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482031009The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482030996The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482030989The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482030972The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device
00810482030965The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device

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