P.F.C. SIGMA 158130000

GUDID 10603295064893

P.F.C. SIGMA TIBIAL TRAY FIXED BEARING MODULAR COCR 3 CEMENTED

DEPUY ORTHOPAEDICS, INC.

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 10603295064893
• NIH Device Record Key: db0012d2-397c-4de8-b7a6-ad018b317ef7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.F.C. SIGMA
• Version Model Number: 1581-30-000
• Catalog Number: 158130000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295064893 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032151

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-09-24

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

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