SIGMA LCS COMPLETE 129453120

GUDID 10603295026228

SIGMA LCS COMPLETE REVISION FEMORAL SLEEVE 34mm

DEPUY ORTHOPAEDICS, INC.

Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge Knee arthroplasty wedge

• Primary Device ID: 10603295026228
• NIH Device Record Key: 8fd84fb3-740d-4e4e-9217-7755d67a53b9
• Commercial Distribution Discontinuation: 2019-11-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SIGMA LCS COMPLETE
• Version Model Number: 1294-53-120
• Catalog Number: 129453120
• 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	10603295026228 [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: 2019-11-18
• Device Publish Date: 2015-03-24

On-Brand Devices [SIGMA LCS COMPLETE]

• 10603295026242: SIGMA LCS COMPLETE REVISION FEMORAL SLEEVE 46mm
• 10603295026235: SIGMA LCS COMPLETE REVISION FEMORAL SLEEVE 40mm
• 10603295026228: SIGMA LCS COMPLETE REVISION FEMORAL SLEEVE 34mm
• 10603295026211: SIGMA LCS COMPLETE REVISION FEMORAL SLEEVE 31mm
• 10603295026204: SIGMA LCS COMPLETE REVISION FEMORAL SLEEVE 20mm