SIGMA RPF AOX 196191011

GUDID 10603295075738

SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1 12.5mm

DEPUY ORTHOPAEDICS, INC.

Tibial insert

• Primary Device ID: 10603295075738
• NIH Device Record Key: 58648708-d111-49d8-8969-59911525d881
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGMA RPF AOX
• Version Model Number: 1961-91-011
• Catalog Number: 196191011
• 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	10603295075738 [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 RPF AOX]

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• 10603295076025: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 6 15mm
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• 10603295076001: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 6 10mm
• 10603295075998: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 5 17.5mm
• 10603295075981: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 5 15mm
• 10603295075974: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 5 12.5mm
• 10603295075967: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 5 10mm
• 10603295075950: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 4 17.5mm
• 10603295075943: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 4 15mm
• 10603295075936: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 4 12.5mm
• 10603295075929: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 4 10mm
• 10603295075912: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 3 17.5mm
• 10603295075905: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 3 15mm
• 10603295075899: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 3 12.5mm
• 10603295075882: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 3 10mm
• 10603295075875: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2.5 17.5mm
• 10603295075868: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2.5 15mm
• 10603295075851: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2.5 12.5mm
• 10603295075844: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2.5 10mm
• 10603295075837: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2 17.5mm
• 10603295075820: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2 15mm
• 10603295075813: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2 12.5mm
• 10603295075806: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 2 10mm
• 10603295075790: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1.5 17.5mm
• 10603295075783: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1.5 15mm
• 10603295075776: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1.5 12.5mm
• 10603295075769: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1.5 10mm
• 10603295075752: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1 17.5mm
• 10603295075745: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1 15mm
• 10603295075738: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1 12.5mm
• 10603295075721: SIGMA TIBIAL INSERT ROTATING PLATFORM RPF AOX SIZE 1 10mm