ProDisc PDLLPT14S

GUDID H981PDLLPT14S0S

POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-14MM-STERILE

SYNTHES (U.S.A.) LP

Lumbar total intervertebral disc replacement prosthesis
Primary Device IDH981PDLLPT14S0S
NIH Device Record Keyde4655f3-4525-41a4-af19-5b6a0589088e
Commercial Distribution StatusIn Commercial Distribution
Brand NameProDisc
Version Model NumberPDL-L-PT14S
Catalog NumberPDLLPT14S
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034700069 [Primary]
HIBCCH981PDLLPT14S0S [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 Date2020-11-06
Device Publish Date2017-02-17

On-Brand Devices [ProDisc]

H981PDLMSP11S0PSUPERIOR END PLATE MEDIUM 11°-STERILE
H981PDLMSP06S0TSUPERIOR END PLATE MEDIUM 6°-STERILE
H981PDLMPT14S0TPOLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-14MM-STERILE
H981PDLMPT12S0RPOLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-12MM-STERILE
H981PDLMPT10S0PPOLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE
H981PDLMIP00S0DINFERIOR END PLATE MEDIUM-STERILE
H981PDLLSP11S0OSUPERIOR END PLATE LARGE 11°-STERILE
H981PDLLSP06S0SSUPERIOR END PLATE LARGE 6°-STERILE
H981PDLLPT14S0SPOLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-14MM-STERILE
H981PDLLPT12S0QPOLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-12MM-STERILE
H981PDLLPT10S0OPOLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10MM-STERILE
H981PDLLIP00S0CINFERIOR END PLATE LARGE-STERILE

Trademark Results [ProDisc]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRODISC
PRODISC
90290075 not registered Live/Pending
Vinpower, Inc.
2020-10-30
PRODISC
PRODISC
76568192 3283354 Live/Registered
DEPUY SYNTHES, INC.
2004-01-05
PRODISC
PRODISC
76141355 not registered Dead/Abandoned
Spine Solutions, Inc.
2000-10-05
PRODISC
PRODISC
74692742 2302337 Dead/Cancelled
DMX, INC.
1995-06-23
PRODISC
PRODISC
74692582 2080621 Live/Registered
DMX, LLC
1995-06-23
PRODISC
PRODISC
74364702 1825609 Dead/Cancelled
Societe JBS (SA)
1993-03-03
PRODISC
PRODISC
74364701 1828186 Live/Registered
DEPUY SYNTHES, INC.
1993-03-03

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