PINNACLE POROCOAT 121701064

GUDID 10603295008613

PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 64mm OD

DEPUY ORTHOPAEDICS, INC.

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell
Primary Device ID10603295008613
NIH Device Record Key10a40adf-c73a-49c8-a3bb-690eac34b6e4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePINNACLE POROCOAT
Version Model Number1217-01-064
Catalog Number121701064
Company DUNS080506581
Company NameDEPUY ORTHOPAEDICS, INC.
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
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
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
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
GS110603295008613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-11
Device Publish Date2015-03-24

On-Brand Devices [PINNACLE POROCOAT]

10603295009894PINNACLE POROCOAT ACETABULAR SHELL SECTOR II 66mm OD
10603295009887PINNACLE POROCOAT ACETABULAR SHELL SECTOR II 64mm OD
10603295009870PINNACLE POROCOAT ACETABULAR SHELL SECTOR II 62mm OD
10603295009863PINNACLE POROCOAT ACETABULAR SHELL SECTOR II 60mm OD
10603295009856PINNACLE POROCOAT ACETABULAR SHELL SECTOR II 58mm OD
10603295009849PINNACLE POROCOAT ACETABULAR SHELL SECTOR II 56mm OD
10603295009832PINNACLE POROCOAT ACETABULAR SHELL SECTOR II 54mm OD
10603295009825PINNACLE POROCOAT ACETABULAR SHELL SECTOR II 52mm OD
10603295009818PINNACLE POROCOAT ACETABULAR SHELL SECTOR II 50mm OD
10603295009801PINNACLE POROCOAT ACETABULAR SHELL SECTOR II 48mm OD
10603295008620PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 66mm OD
10603295008613PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 64mm OD
10603295008606PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 62mm OD
10603295008590PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 60mm OD
10603295008583PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 58mm OD
10603295008576PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 56mm OD
10603295008569PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 54mm OD
10603295008552PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 52mm OD
10603295008545PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 50mm OD
10603295008538PINNACLE POROCOAT ACETABULAR SHELL 100 SERIES 48mm OD
10603295009696PINNACLE POROCOAT ACETABULAR SHELL MULTI-HOLE II 66mm OD
10603295009689PINNACLE POROCOAT ACETABULAR SHELL MULTI-HOLE II 64mm OD
10603295009672PINNACLE POROCOAT ACETABULAR SHELL MULTI-HOLE II 62mm OD
10603295009665PINNACLE POROCOAT ACETABULAR SHELL MULTI-HOLE II 60mm OD
10603295009658PINNACLE POROCOAT ACETABULAR SHELL MULTI-HOLE II 58mm OD
10603295009641PINNACLE POROCOAT ACETABULAR SHELL MULTI-HOLE II 56mm OD
10603295009634PINNACLE POROCOAT ACETABULAR SHELL MULTI-HOLE II 54mm OD
10603295009627PINNACLE POROCOAT ACETABULAR SHELL MULTI-HOLE II 52mm OD
10603295009610PINNACLE POROCOAT ACETABULAR SHELL MULTIHOLE II 50mm OD
10603295009603PINNACLE POROCOAT ACETABULAR SHELL MULTI-HOLE II 48mm OD
10603295008729PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 66mm OD
10603295008712PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 64mm OD
10603295008705PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 62mm OD
10603295008699PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 60mm OD
10603295008682PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 58mm OD
10603295008675PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 56mm OD
10603295008668PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 54mm OD
10603295008651PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 52mm OD
10603295008644PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 50mm OD
10603295008637PINNACLE POROCOAT ACETABULAR SHELL 300 SERIES 48mm OD

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