Prodisc C

GUDID 10705034763804

PRODISC-C IMPLANT LARGE 7MM-STERILE

Centinel Spine, Inc.

Cervical total disc replacement prosthesis, sterile 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 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 ID10705034763804
NIH Device Record Key662b7f98-c275-425e-a8c8-9682d9e5d6ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameProdisc C
Version Model Number09.820.047S
Company DUNS949024850
Company NameCentinel Spine, Inc.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843193112835 [Primary]
GS110705034763804 [Previous]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-16
Device Publish Date2018-10-16

On-Brand Devices [Prodisc C]

10705034763897PRODISC-C IMPLANT EXTRA LARGE DEEP 7MM-STERILE
10705034763880PRODISC-C IMPLANT EXTRA LARGE DEEP 6MM-STERILE
10705034763873PRODISC-C IMPLANT EXTRA LARGE DEEP 5MM-STERILE
10705034763866PRODISC-C IMPLANT EXTRA LARGE 7MM-STERILE
10705034763859PRODISC-C IMPLANT EXTRA LARGE 6MM-STERILE
10705034763842PRODISC-C IMPLANT EXTRA LARGE 5MM-STERILE
10705034763835PRODISC-C IMPLANT LARGE DEEP 7MM-STERILE
10705034763828PRODISC-C IMPLANT LARGE DEEP 6MM-STERILE
10705034763811PRODISC-C IMPLANT LARGE DEEP 5MM-STERILE
10705034763804PRODISC-C IMPLANT LARGE 7MM-STERILE
10705034763798PRODISC-C IMPLANT LARGE 6MM-STERILE
10705034763781PRODISC-C IMPLANT LARGE 5MM-STERILE
10705034763774PRODISC-C IMPLANT MEDIUM DEEP 7MM-STERILE
10705034763767PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE
10705034763750PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE
10705034763743PRODISC-C IMPLANT MEDIUM 7MM-STERILE
10705034763736PRODISC-C IMPLANT MEDIUM 6MM-STERILE
10705034763729PRODISC-C IMPLANT MEDIUM 5MM-STERILE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.