P.F.C. SIGMA 158196753

GUDID 10603295065449

P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 4 15mm CEMENTED

DEPUY ORTHOPAEDICS, INC.

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID10603295065449
NIH Device Record Keyffa45e99-d3d8-4e45-8b41-cd18686b1762
Commercial Distribution StatusIn Commercial Distribution
Brand NameP.F.C. SIGMA
Version Model Number1581-96-753
Catalog Number158196753
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295065449 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-09-24

On-Brand Devices [P.F.C. SIGMA]

10603295232803P.F.C. SIGMA PATELLA OVAL DOME 1-PEG 38mm CEMENTED
10603295232445P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 2.5 RIGHT
10603295232421P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 1.5 RIGHT
10603295232414P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 6 RIGHT
10603295232407P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 5 RIGHT
10603295232384P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 4 RIGHT
10603295232360P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 3 RIGHT
10603295232346P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 2 RIGHT
10603295232308P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 2.5 LEFT
10603295232285P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 1.5 LEFT
10603295232261P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 6 LEFT
10603295232254P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 5 LEFT
10603295232247P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 4 LEFT
10603295232230P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 3 LEFT
10603295232223P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 2 LEFT
10603295216834P.F.C. SIGMA TIBIAL TRAY FIXED BEARING MODULAR TITANIUM 2.5 CEMENTED
10603295216827P.F.C. SIGMA TIBIAL TRAY FIXED BEARING MODULAR TITANIUM 1.5 CEMENTED
10603295216810P.F.C. SIGMA TIBIAL TRAY FIXED BEARING MODULAR TITANIUM 6 CEMENTED
10603295216803P.F.C. SIGMA TIBIAL TRAY FIXED BEARING MODULAR TITANIUM 5 CEMENTED
10603295216797P.F.C. SIGMA TIBIAL TRAY FIXED BEARING MODULAR TITANIUM 4 CEMENTED
10603295216780P.F.C. SIGMA TIBIAL TRAY FIXED BEARING MODULAR TITANIUM 3 CEMENTED
10603295216469P.F.C. SIGMA TIBIAL TRAY FIXED BEARING KEEL TITANIUM 6 CEMENTED
10603295216445P.F.C. SIGMA TIBIAL TRAY FIXED BEARING KEEL TITANIUM 4 CEMENTED
10603295216438P.F.C. SIGMA TIBIAL TRAY FIXED BEARING KEEL TITANIUM 3 CEMENTED
10603295216421P.F.C. SIGMA TIBIAL TRAY FIXED BEARING KEEL TITANIUM 2 CEMENTED
10603295216391P.F.C. SIGMA TIBIAL TRAY FIXED BEARING KEEL TITANIUM 2.5 CEMENTED
10603295216384P.F.C. SIGMA TIBIAL TRAY FIXED BEARING KEEL TITANIUM 1.5 CEMENTED
10603295152484P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 2.5 LEFT
10603295152477P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 6 LEFT
10603295152453P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 4 LEFT
10603295152446P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 3 LEFT
10603295152439P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 2 LEFT
10603295152422P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 2.5 RIGHT
10603295152415P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 6 RIGHT
10603295152408P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 5 RIGHT
10603295152392P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 4 RIGHT
10603295152385P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 3 RIGHT
10603295152378P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING OPEN BOX CEMENTED 2 RIGHT
10603295074793P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 4N RIGHT
10603295074786P.F.C. SIGMA FEMORAL CRUCIATE SUBSTITUTING CEMENTED 4N LEFT
10603295065487P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 5 15mm CEMENTED
10603295065470P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 5 12.5mm CEMENTED
10603295065463P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 5 10mm CEMENTED
10603295065456P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 5 8mm CEMENTED
10603295065449P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 4 15mm CEMENTED
10603295065432P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 4 12.5mm CEMENTED
10603295065425P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 4 10mm CEMENTED
10603295065401P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 3 15mm CEMENTED
10603295065395P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 3 12.5mm CEMENTED
10603295065388P.F.C. SIGMA TIBIAL COMPONENT ALL POLY STABILIZED 3 10mm CEMENTED

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