SynFix-LR 08802019S

GUDID H98108802019S0

SYNFIX-LR 30MM DEPTH/38MM WIDTH/12MM HEIGHT 12DEG-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 Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device IDH98108802019S0
NIH Device Record Key1bc26664-ef7b-4383-83c9-3833ff5bd789
Commercial Distribution Discontinuation2021-09-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSynFix-LR
Version Model Number08.802.019S
Catalog Number08802019S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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 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
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034754017 [Primary]
HIBCCH98108802019S0 [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 Date2021-10-13
Device Publish Date2015-09-14

On-Brand Devices [SynFix-LR]

H981608021030MODULE FOR 4.0MM TI SYNFIX(TM)-LR LOCKING SCREWS
07611819297227SCREW HOLDING INSTRUMENT FOR SYNFIX(TM)-LR
07611819297234IMPLANT HOLDER FOR SYNFIX(TM)-LR
H98108802004S0SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 12DEG-STER
H98108802003S0SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/19MM HEIGHT 8DEG-STER
H98108802002S0SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/17MM HEIGHT 8DEG-STER
H98108802001S0SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/15MM HEIGHT 8DEG-STER
H98108802000S0SYNFIX(TM)-LR 26MM DEPTH/32MM WIDTH/13.5MM HEIGHT 8DEG-STER
H9810480221304.0MM TI LOCKING SCREW-FINE TIP 30MM FOR SYNFIX-LR
0761181931098819MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
0761181931097117MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
0761181931096415MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
0761181931095713.5MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
0761181931094012MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
07611819939028SYNFIX(TM)-LR QUICK INSERTER/DISTRACTOR (SQUID)
07611819297425PACKING BLOCK FOR 30MM DEPTH/ 38MM WIDTH SYNFIX(TM)-LR
07611819791268PACKING BLOCK FOR 26MM DEPTH/ 32MM WIDTH SYNFIX(TM)-LR
07611819791251AIMING DEVICE 15MM FOR SYNFIX(TM)-LR
07611819297272AIMING DEVICE 19MM FOR SYNFIX(TM)-LR
07611819297265AIMING DEVICE 17MM FOR SYNFIX(TM)-LR
07611819297258AIMING DEVICE 13.5MM FOR SYNFIX(TM)-LR
07611819297197AIMING DEVICE HOLDER FOR SYNFIX(TM)-LR
07611819973091AIMING DEVICE FOR 12MM SYNFIX-LR
07611819973084SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 30MM/W 38MM/H 12MM
07611819973077SYNFIX-LR TRIAL IMPLANT 8DEG DEPTH 30MM/W 38MM/H 12MM
07611819973060SYNFIX-LR TRIAL IMPLANT 12DEG DEPTH 26MM/W 32MM/H 12MM
07611819973053SYNFIX-LR TRIAL IMPLANT 8DEG DEPTH 26MM/W 32MM/H 12MM
H981608091500SYNFIX® LR IMPLANT HOLDER GRAPHIC CASE
H981608022400MODULE FOR SYNFIX-LR AIMING DEVICES
H981608021300GRAPHIC CASE FOR SYNFIX-LR TRIAL SPACERS AND SCREWS
H981608021100GRAPHIC CASE FOR SYNFIX-LR STANDARD INSTRUMENTS
H98108802019S0SYNFIX-LR 30MM DEPTH/38MM WIDTH/12MM HEIGHT 12DEG-STER
H98108802018S0SYNFIX-LR 30MM DEPTH/38MM WIDTH/12MM HEIGHT 8DEG-STER
H98108802017S0SYNFIX-LR 26MM DEPTH/32MM WIDTH/12MM HEIGHT 12DEG-STER
H98108802016S0SYNFIX-LR 26MM DEPTH/32MM WIDTH/12MM HEIGHT 8DEG-STER

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