ProDisc-C 09820037S

GUDID H98109820037S04

PRODISC-C IMPLANT MEDIUM DEEP 7MM-STERILE

SYNTHES (U.S.A.) LP

Cervical total disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc replacement prosthesis Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular Cervical total intervertebral disc prosthesis, modular
Primary Device IDH98109820037S04
NIH Device Record Key62eb5768-ed3a-4f49-825b-2c71480dc868
Commercial Distribution StatusIn Commercial Distribution
Brand NameProDisc-C
Version Model Number09.820.037S
Catalog Number09820037S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
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
GS110705034763774 [Primary]
HIBCCH98109820037S04 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJOPROSTHESIS, INTERVERTEBRAL DISC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2014-09-08

On-Brand Devices [ProDisc-C]

H98109820077S08PRODISC-C IMPLANT EXTRA LARGE DEEP 7MM-STERILE
H98109820076S07PRODISC-C IMPLANT EXTRA LARGE DEEP 6MM-STERILE
H98109820075S06PRODISC-C IMPLANT EXTRA LARGE DEEP 5MM-STERILE
H98109820067S07PRODISC-C IMPLANT EXTRA LARGE 7MM-STERILE
H98109820066S06PRODISC-C IMPLANT EXTRA LARGE 6MM-STERILE
H98109820065S05PRODISC-C IMPLANT EXTRA LARGE 5MM-STERILE
H98109820057S06PRODISC-C IMPLANT LARGE DEEP 7MM-STERILE
H98109820056S05PRODISC-C IMPLANT LARGE DEEP 6MM-STERILE
H98109820055S04PRODISC-C IMPLANT LARGE DEEP 5MM-STERILE
H98109820047S05PRODISC-C IMPLANT LARGE 7MM-STERILE
H98109820046S04PRODISC-C IMPLANT LARGE 6MM-STERILE
H98109820045S03PRODISC-C IMPLANT LARGE 5MM-STERILE
H98109820037S04PRODISC-C IMPLANT MEDIUM DEEP 7MM-STERILE
H98109820036S03PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE
H98109820035S02PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE
H98109820027S03PRODISC-C IMPLANT MEDIUM 7MM-STERILE
H98109820026S02PRODISC-C IMPLANT MEDIUM 6MM-STERILE
H98109820025S01PRODISC-C IMPLANT MEDIUM 5MM-STERILE
H981608200040SCREW MODULE FOR PRODISC-C
H981608200030GRAPHIC CASE FOR PRODISC-C REMOVAL SYSTEM
07611819960640GRAPHIC CASE FOR PRODISC-C(TM) INSTRUMENTS

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