LCS SIGMA 129433115

GUDID 10603295025757

LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 1.5 CEMENTED

DEPUY ORTHOPAEDICS, INC.

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 10603295025757
• NIH Device Record Key: 998c9b09-84e2-4927-875c-3d2e7bfb517e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LCS SIGMA
• Version Model Number: 1294-33-115
• Catalog Number: 129433115
• 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
• 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	10603295025757 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P830055

FDA Product Code

• NJL: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-24
• Device Publish Date: 2015-03-24

On-Brand Devices [LCS SIGMA]

• 10603295025825: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 7 CEMENTED
• 10603295025818: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 6 CEMENTED
• 10603295025795: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 4 CEMENTED
• 10603295025788: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 3 CEMENTED
• 10603295025771: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 2.5 CEMENTED
• 10603295025764: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 2 CEMENTED
• 10603295025757: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 1.5 CEMENTED
• 10603295025641: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE 7 CEMENTED
• 10603295025634: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE 6 CEMENTED
• 10603295025627: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE 5 CEMENTED
• 10603295025610: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE 4 CEMENTED
• 10603295025603: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE 3 CEMENTED
• 10603295025597: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE 2.5 CEMENTED
• 10603295025573: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE 1.5 CEMENTED
• 10603295025566: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE 1 CEMENTED
• 10603295025801: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 5 CEMENTED
• 10603295025740: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 1 CEMENTED
• 10603295025580: LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT CONE SIZE 2 CEMENTED