SIGMA LCS COMPLETE 129453120

GUDID 10603295026228

SIGMA LCS COMPLETE REVISION FEMORAL SLEEVE 34mm

DEPUY ORTHOPAEDICS, INC.

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