SIGMA AOX 196192154

GUDID 10603295076681

SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 5 17.5mm

DEPUY ORTHOPAEDICS, INC.

Tibial insert

• Primary Device ID: 10603295076681
• NIH Device Record Key: 0ed7afe9-ceda-47d5-bdef-a4ab37c9cf8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGMA AOX
• Version Model Number: 1961-92-154
• Catalog Number: 196192154
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295076681 [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: 2020-12-04
• Device Publish Date: 2015-03-24

On-Brand Devices [SIGMA AOX]

• 10603295076780: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 6 25mm
• 10603295076773: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 6 22.5mm
• 10603295076766: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 6 20mm
• 10603295076759: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 6 17.5mm
• 10603295076742: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 6 15mm
• 10603295076735: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 6 12.5mm
• 10603295076728: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 6 10mm
• 10603295076711: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 5 25mm
• 10603295076704: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 5 22.5mm
• 10603295076698: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 5 20mm
• 10603295076681: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 5 17.5mm
• 10603295076674: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 5 15mm
• 10603295076667: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 5 12.5mm
• 10603295076650: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 5 10mm
• 10603295076643: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 4 25mm
• 10603295076636: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 4 22.5mm
• 10603295076629: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 4 20mm
• 10603295076612: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 4 17.5mm
• 10603295076605: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 4 15mm
• 10603295076599: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 4 12.5mm
• 10603295076582: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 4 10mm
• 10603295076575: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 3 25mm
• 10603295076568: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 3 22.5mm
• 10603295076551: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 3 20mm
• 10603295076544: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 3 17.5mm
• 10603295076537: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 3 15mm
• 10603295076520: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 3 12.5mm
• 10603295076513: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 3 10mm
• 10603295076506: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2.5 25mm
• 10603295076490: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2.5 22.5mm
• 10603295076483: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2.5 20mm
• 10603295076476: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2.5 17.5mm
• 10603295076469: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2.5 15mm
• 10603295076452: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2.5 12.5mm
• 10603295076445: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2.5 10mm
• 10603295076438: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2 25mm
• 10603295076421: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2 22.5mm
• 10603295076414: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2 20mm
• 10603295076407: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2 17.5mm
• 10603295076391: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2 15mm
• 10603295076384: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2 12.5mm
• 10603295076377: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2 10mm
• 10603295076360: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 1.5 20mm
• 10603295076353: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 1.5 17.5mm
• 10603295076346: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 1.5 15mm
• 10603295076339: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 1.5 12.5mm
• 10603295076322: SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 1.5 10mm
• 10603295076315: SIGMA TIBIAL INSERT ROTATING PLATFORM CURVED AOX SIZE 6 17.5mm
• 10603295076308: SIGMA TIBIAL INSERT ROTATING PLATFORM CURVED AOX SIZE 6 15mm
• 10603295076292: SIGMA TIBIAL INSERT ROTATING PLATFORM CURVED AOX SIZE 6 12.5mm