SIGMA LCS COMPLETE POROCOAT 129434150

GUDID 10603295025894

SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 5 CEMENTLESS

DEPUY ORTHOPAEDICS, INC.

Coated knee tibia prosthesis

• Primary Device ID: 10603295025894
• NIH Device Record Key: 8b60ee1d-8d22-48f6-89d3-c1d653840892
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGMA LCS COMPLETE POROCOAT
• Version Model Number: 1294-34-150
• Catalog Number: 129434150
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295025894 [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: 4
• Public Version Date: 2020-03-24
• Device Publish Date: 2015-03-24

On-Brand Devices [SIGMA LCS COMPLETE POROCOAT]

• 10603295025917: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 7 CEMENTLESS
• 10603295025900: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 6 CEMENTLESS
• 10603295025894: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 5 CEMENTLESS
• 10603295025887: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 4 CEMENTLESS
• 10603295025870: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 3 CEMENTLESS
• 10603295025863: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 2.5 CEMENTLESS
• 10603295025849: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 1.5 CEMENTLESS
• 10603295025832: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 1 CEMENTLESS
• 10603295025733: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 7 CEMENTLESS
• 10603295025726: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 6 CEMENTLESS
• 10603295025719: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 5 CEMENTLESS
• 10603295025702: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 4 CEMENTLESS
• 10603295025696: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 3 CEMENTLESS
• 10603295025689: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 2.5 CEMENTLESS
• 10603295025672: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 2 CEMENTLESS
• 10603295025665: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 1.5 CEMENTLESS
• 10603295025658: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. CONE POROCOAT SIZE 1 CEMENTLESS
• 10603295025856: SIGMA LCS COMPLETE TIBIAL TRAY ROTATING PLATFORM M.B.T. KEEL POROCOAT SIZE 2 CEMENTLESS