SYNFIX Evolution 0483523002S

GUDID 20705034816163

SYNFIX® EVOLUTION SCREW/30MM STERILE

Synthes GmbH

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile
Primary Device ID20705034816163
NIH Device Record Key6fd1b191-9534-42c2-8c11-a0dd0b7b9393
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNFIX Evolution
Version Model Number04.835.230.02S
Catalog Number0483523002S
Company DUNS486711679
Company NameSynthes GmbH
Device Count2
DM Exempttrue
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 Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS120705034816163 [Primary]
GS180705034816165 [Unit of Use]
HIBCCH9810483523002 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-27
Device Publish Date2017-02-17

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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