SYNFIX Evolution 03835402

GUDID 07612334154675

SYNFIX® EVOLUTION MINI-OPEN AIMING DEVICE/13.5MM & 15MM

Synthes GmbH

Orthopaedic implant aiming/guiding block, reusable
Primary Device ID07612334154675
NIH Device Record Key12a79cad-ba76-4efc-893c-3c5768a85e58
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNFIX Evolution
Version Model Number03.835.402
Catalog Number03835402
Company DUNS486711679
Company NameSynthes GmbH
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

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS107612334154675 [Direct Marking]
GS110705034821351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


[07612334154675]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-04-27
Device Publish Date2019-07-29

On-Brand Devices [SYNFIX Evolution]

07612334084262SYNFIX® EVO FOOTPRINT TRIAL LARGE/LARGE DEEP
07612334084255SYNFIX® EVO FOOTPRINT TRIAL MEDIUM/MEDIUM DEEP
07612334081643SYNFIX® EVO FOOTPRINT TRIAL SMALL/SMALL DEEP
07612334154729SYNFIX® EVOLUTION MINI-OPEN AWL
07612334154712SYNFIX® EVOLUTION MINI-OPEN SCREWDRIVER/SHORT
07612334154705SYNFIX® EVOLUTION MINI-OPEN DRIVER W/O THREAD LOCK SLEEVE
07612334154699SYNFIX® EVOLUTION MINI-OPEN SCREWDRIVER
07612334154682SYNFIX® EVOLUTION MINI-OPEN AIMING DEVICE/17MM & 19MM
07612334154675SYNFIX® EVOLUTION MINI-OPEN AIMING DEVICE/13.5MM & 15MM
07612334154668SYNFIX® EVOLUTION MINI-OPEN AIMING DEVICE/10.5MM & 12MM
10705034817538SYNFIX® EVOLUTION THREAD LOCK SLEEVE - STERILE
07611819681293SYNFIX® EVOLUTION TRIAL SPACER LARGE/19MM HEIGHT/6°
07611819681286SYNFIX® EVOLUTION TRIAL SPACER LARGE/17MM HEIGHT/6°
07611819681279SYNFIX® EVOLUTION TRIAL SPACER LARGE/15MM HEIGHT/6°
07611819681262SYNFIX® EVOLUTION TRIAL SPACER LARGE/13.5MM HEIGHT/6°
07611819681255SYNFIX® EVOLUTION TRIAL SPACER LARGE/12MM HEIGHT/6°
07611819681248SYNFIX® EVOLUTION TRIAL SPACER LARGE/10.5MM HEIGHT/6°
07611819681460SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/19MM HEIGHT/6°
07611819681453SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/17MM HEIGHT/6°
07611819681446SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/15MM HEIGHT/6°
07611819681521SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/19MM HEIGHT/10°
07611819681514SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/17MM HEIGHT/10°
07611819681507SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/15MM HEIGHT/10°
07611819681491SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/13.5MM HEIGHT/10°
07611819681439SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/13.5MM HEIGHT/6°
07611819681484SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/12MM HEIGHT/10°
07611819681422SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/12MM HEIGHT/6°
07611819681477SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/10.5MM HEIGHT/10°
07611819681354SYNFIX® EVOLUTION TRIAL SPACER LARGE/19MM HEIGHT/10°
07611819681347SYNFIX® EVOLUTION TRIAL SPACER LARGE/17MM HEIGHT/10°
07611819681330SYNFIX® EVOLUTION TRIAL SPACER LARGE/15MM HEIGHT/10°
07611819681323SYNFIX® EVOLUTION TRIAL SPACER LARGE/13.5MM HEIGHT/10°
07611819681316SYNFIX® EVOLUTION TRIAL SPACER LARGE/12MM HEIGHT/10°
07611819681309SYNFIX® EVOLUTION TRIAL SPACER LARGE/10.5MM HEIGHT/10°
07611819681613SYNFIX® EVOLUTION TRIAL SPACER LARGE/19MM HEIGHT/18°
07611819681606SYNFIX® EVOLUTION TRIAL SPACER LARGE/17MM HEIGHT/18°
07611819681590SYNFIX® EVOLUTION TRIAL SPACER LARGE/15MM HEIGHT/18°
07611819681583SYNFIX® EVOLUTION TRIAL SPACER LARGE/13.5MM HEIGHT/18°
07611819681651SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/19MM HEIGHT/18°
07611819681644SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/17MM HEIGHT/18°
07611819681637SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/15MM HEIGHT/18°
07611819681620SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/13.5MM HEIGHT/18°
07611819681576SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/19MM HEIGHT/14°
07611819681569SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/17MM HEIGHT/14°
07611819681552SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/15MM HEIGHT/14°
07611819681545SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/13.5MM HEIGHT/14°
07611819681538SYNFIX® EVOLUTION TRIAL SPACER LARGE DEEP/12MM HEIGHT/14°
07611819681408SYNFIX® EVOLUTION TRIAL SPACER LARGE/19MM HEIGHT/14°
07611819681392SYNFIX® EVOLUTION TRIAL SPACER LARGE/17MM HEIGHT/14°
07611819681385SYNFIX® EVOLUTION TRIAL SPACER LARGE/15MM HEIGHT/14°

Trademark Results [SYNFIX Evolution]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYNFIX EVOLUTION
SYNFIX EVOLUTION
86268391 5114907 Live/Registered
DEPUY SYNTHES, INC.
2014-05-01
SYNFIX EVOLUTION
SYNFIX EVOLUTION
85187900 not registered Dead/Abandoned
DEPUY SYNTHES, INC.
2010-12-01

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