129435215

GUDID 10603295026006

TIBIAL TRAY ROTATING PLATFORM M.B.T. REVISION THICK TRAY SIZE 2 15mm CEMENTED

DEPUY ORTHOPAEDICS, INC.

Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 10603295026006
• NIH Device Record Key: 07fda621-f20b-4afc-8139-a24d162c953b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1294-35-215
• Catalog Number: 129435215
• 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	10603295026006 [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: 2019-12-11
• Device Publish Date: 2015-03-24

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• 10603295551560 - ATTUNE: 2024-05-13 ATTUNE KNEE SYSTEM FLEXION SIZER-BALANCER ASSEMBLY
• 10603295551577 - ATTUNE: 2024-05-13 ATTUNE KNEE SYSTEM FLEXION SIZER-BALANCER STYLUS
• 10603295551584 - ATTUNE: 2024-05-13 ATTUNE KNEE SYSTEM FLEXION SIZER-BALANCER CR FOOT
• 10603295551591 - ATTUNE: 2024-05-13 ATTUNE KNEE SYSTEM FLEXION SIZER-BALANCER PS FOOT
• 10603295551607 - ATTUNE: 2024-05-13 ATTUNE KNEE SYSTEM FLEXION SIZER-BALANCER TRAY
• 10603295548928 - EMPHASYS: 2024-05-08 EMPHASYS MAKE TO ORDER SHORTENED TIP