SIGMA AOX 196192113

GUDID 10603295076391

SIGMA TIBIAL INSERT ROTATING PLATFORM STABILIZED AOX SIZE 2 15mm

DEPUY ORTHOPAEDICS, INC.

Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert

• Primary Device ID: 10603295076391
• NIH Device Record Key: 6e4f867f-233c-4922-a70d-733d31d029c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGMA AOX
• Version Model Number: 1961-92-113
• Catalog Number: 196192113
• 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	10603295076391 [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