SYNFIX Evolution 08815233S

GUDID H98108815233S0

SYNFIX® EVOLUTION SPACER MED DEEP/13.5MM HEIGHT/6°-STER

SYNTHES (U.S.A.) LP

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device IDH98108815233S0
NIH Device Record Keya61a8578-4844-483d-b276-df0661497068
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNFIX Evolution
Version Model Number08.815.233S
Catalog Number08815233S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
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
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
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
GS110705034814247 [Primary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]
HIBCCH98108815233S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar
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 Date2020-09-16
Device Publish Date2016-06-30

On-Brand Devices [SYNFIX Evolution]

H9810483523002SSYNFIX® EVOLUTION SCREW/30MM STERILE
H9810483522502S0SYNFIX® EVOLUTION SCREW/25MM STERILE
H9810483522002S0SYNFIX® EVOLUTION SCREW/20MM STERILE
H9810483513002S0SYNFIX® EVOLUTION FINE TIP SCREW/30MM - STERILE
H9810483512502S0SYNFIX® EVOLUTION FINE TIP SCREW/25MM - STERILE
H9810483512002S0SYNFIX® EVOLUTION FINE TIP SCREW/20MM - STERILE
07611819682672SCREW LOADING STATION FOR SYNFIX® EVOLUTION
07611819682719SYNFIX® EVOLUTION TRIAL SPACER HOLDER
H98108815356S0SYNFIX® EVOLUTION SPACER LG DEEP/19MM HEIGHT/14°-STER
H98108815355S0SYNFIX® EVOLUTION SPACER LG DEEP/17MM HEIGHT/14°-STER
H98108815354S0SYNFIX® EVOLUTION SPACER LG DEEP/15MM HEIGHT/14°-STER
H98108815353S0SYNFIX® EVOLUTION SPACER LG DEEP/13.5MM HEIGHT/14°-STER
H98108815352S0SYNFIX® EVOLUTION SPACER LG DEEP/12MM HEIGHT/14°-STER
H98108815346S0SYNFIX® EVOLUTION SPACER LG DEEP/19MM HEIGHT/10°-STER
H98108815345S0SYNFIX® EVOLUTION SPACER LG DEEP/17MM HEIGHT/10°-STER
H98108815344S0SYNFIX® EVOLUTION SPACER LG DEEP/15MM HEIGHT/10°-STER
H98108815343S0SYNFIX® EVOLUTION SPACER LG DEEP/13.5MM HEIGHT/10°-STER
H98108815342S0SYNFIX® EVOLUTION SPACER LG DEEP/12MM HEIGHT/10°-STER
H98108815341S0SYNFIX® EVOLUTION SPACER LG DEEP/10.5MM HEIGHT/10°-STER
H98108815336S0SYNFIX® EVOLUTION SPACER LG DEEP/19MM HEIGHT/6°-STER
H98108815335S0SYNFIX® EVOLUTION SPACER LG DEEP/17MM HEIGHT/6°-STER
H98108815334S0SYNFIX® EVOLUTION SPACER LG DEEP/15MM HEIGHT/6°-STER
H98108815333S0SYNFIX® EVOLUTION SPACER LG DEEP/13.5MM HEIGHT/6°-STER
H98108815332S0SYNFIX® EVOLUTION SPACER LG DEEP/12MM HEIGHT/6°-STER
H98108815331S0SYNFIX® EVOLUTION SPACER LG DEEP/10.5MM HEIGHT/6°-STER
H98108815365S0SYNFIX® EVOLUTION SPACER LARGE/17MM HEIGHT/18°-STER
H98108815364S0SYNFIX® EVOLUTION SPACER LARGE/15MM HEIGHT/18°-STER
H98108815363S0SYNFIX® EVOLUTION SPACER LARGE/13.5MM HEIGHT/18°-STER
H98108815226S0SYNFIX® EVOLUTION SPACER MED/19MM HEIGHT/14°-STERILE
H98108815225S0SYNFIX® EVOLUTION SPACER MED/17MM HEIGHT/14°-STERILE
H98108815224S0SYNFIX® EVOLUTION SPACER MED/15MM HEIGHT/14°-STERILE
H98108815223S0SYNFIX® EVOLUTION SPACER MED/13.5MM HEIGHT/14°-STERILE
H98108815222S0SYNFIX® EVOLUTION SPACER MED/12MM HEIGHT/14°-STERILE
H98108815216S0SYNFIX® EVOLUTION SPACER MED/19MM HEIGHT/10°-STERILE
H98108815215S0SYNFIX® EVOLUTION SPACER MED/17MM HEIGHT/10°-STERILE
H98108815214S0SYNFIX® EVOLUTION SPACER MED/15MM HEIGHT/10°-STERILE
H98108815213S0SYNFIX® EVOLUTION SPACER MED/13.5MM HEIGHT/10°-STERILE
H98108815212S0SYNFIX® EVOLUTION SPACER MED/12MM HEIGHT/10°-STERILE
H98108815211S0SYNFIX® EVOLUTION SPACER MED/10.5MM HEIGHT/10°-STERILE
H98108815206S0SYNFIX® EVOLUTION SPACER MED/19MM HEIGHT/6°-STERILE
H98108815205S0SYNFIX® EVOLUTION SPACER MED/17MM HEIGHT/6°-STERILE
H98108815204S0SYNFIX® EVOLUTION SPACER MED/15MM HEIGHT/6°-STERILE
H98108815203S0SYNFIX® EVOLUTION SPACER MED/13.5MM HEIGHT/6°-STERILE
H98108815202S0SYNFIX® EVOLUTION SPACER MED/12MM HEIGHT/6°-STERILE
H98108815201S0SYNFIX® EVOLUTION SPACER MED/10.5MM HEIGHT/6°-STERILE
H98108815126S0SYNFIX® EVOLUTION SPACER SMALL/19MM HEIGHT/14°-STERILE
H98108815125S0SYNFIX® EVOLUTION SPACER SMALL/17MM HEIGHT/14°-STERILE
H98108815124S0SYNFIX® EVOLUTION SPACER SMALL/15MM HEIGHT/14°-STERILE
H98108815123S0SYNFIX® EVOLUTION SPACER SMALL/13.5MM HEIGHT/14°-STER
H98108815122S0SYNFIX® EVOLUTION SPACER SMALL/12MM HEIGHT/14°-STERILE

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.