SIGMA 866469

GUDID 10603295217183

SIGMA TAPER STEM 15mm x 90mm CEMENTED

DEPUY ORTHOPAEDICS, INC.

Knee femur stem prosthesis

• Primary Device ID: 10603295217183
• NIH Device Record Key: b56f9a7e-af62-4c20-a6c8-10391a13f7ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGMA
• Version Model Number: 86-6469
• Catalog Number: 866469
• 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	10603295217183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241000
• Premarket Notification: K882234

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: 2020-04-20
• Device Publish Date: 2015-09-24

On-Brand Devices [SIGMA]

• 10603295083740: SIGMA HP PARTIAL KNEE-UNI/TROCHLEA SYSTEM HANDLE
• 10603295083290: SIGMA HP PARTIAL KNEE FEMORAL INTRODUCER
• 10603295084068: SIGMA HP PARTIAL KNEE-TROCHLEA BONE FILE
• 10603295232599: SIGMA FEMORAL TC3 CEMENTED 2.5 RIGHT
• 10603295232582: SIGMA FEMORAL TC3 CEMENTED 1.5 RIGHT
• 10603295232575: SIGMA FEMORAL TC3 CEMENTED 5 RIGHT
• 10603295232568: SIGMA FEMORAL TC3 CEMENTED 4 RIGHT
• 10603295232551: SIGMA FEMORAL TC3 CEMENTED 3 RIGHT
• 10603295232544: SIGMA FEMORAL TC3 CEMENTED 2 RIGHT
• 10603295232537: SIGMA FEMORAL TC3 CEMENTED 2.5 LEFT
• 10603295232520: SIGMA FEMORAL TC3 CEMENTED 1.5 LEFT
• 10603295232513: SIGMA FEMORAL TC3 CEMENTED 5 LEFT
• 10603295232506: SIGMA FEMORAL TC3 CEMENTED 4 LEFT
• 10603295232490: SIGMA FEMORAL TC3 CEMENTED 3 LEFT
• 10603295232483: SIGMA FEMORAL TC3 CEMENTED 2 LEFT
• 10603295232070: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 2.5 RIGHT
• 10603295232063: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 1.5 RIGHT
• 10603295232056: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 6 RIGHT
• 10603295232049: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 5 RIGHT
• 10603295232032: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 4 RIGHT
• 10603295232025: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 3 RIGHT
• 10603295232018: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 2 RIGHT
• 10603295232001: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 2.5 LEFT
• 10603295231998: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 1.5 LEFT
• 10603295231981: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 6 LEFT
• 10603295231974: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 5 LEFT
• 10603295231967: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 4 LEFT
• 10603295231950: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 3 LEFT
• 10603295231943: SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 2 LEFT
• 10603295075523: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 2.5 RIGHT
• 10603295075516: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 1.5 RIGHT
• 10603295075509: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 6 RIGHT
• 10603295075493: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 5 RIGHT
• 10603295075479: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 3 RIGHT
• 10603295075356: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 4N LEFT
• 10603295075349: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 2.5 LEFT
• 10603295075325: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 6 LEFT
• 10603295075318: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 5 LEFT
• 10603295075301: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 4 LEFT
• 10603295075288: SIGMA FEMORAL POSTERIOR STABILIZED LUGGED CEMENTED SIZE 2 LEFT
• 10603295075172: SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 6 RIGHT
• 10603295075158: SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 4N RIGHT
• 10603295075141: SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 4 RIGHT
• 10603295075134: SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 3 RIGHT
• 10603295075127: SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 2.5 RIGHT
• 10603295075110: SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 2 RIGHT
• 10603295075103: SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 1.5 RIGHT
• 10603295075073: SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 5 LEFT
• 10603295075059: SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 4 LEFT
• 10603295075042: SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 3 LEFT