129435110

GUDID 10603295025924

TIBIAL TRAY ROTATING PLATFORM M.B.T. REVISION SIZE 1 CEMENTED

DEPUY ORTHOPAEDICS, INC.

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 10603295025924
• NIH Device Record Key: d6854129-e210-42e2-8fa0-51440a731570
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1294-35-110
• Catalog Number: 129435110
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295025924 [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

Devices Manufactured by DEPUY ORTHOPAEDICS, INC.

• 10603295552628 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE SHIM 1.0 mm
• 10603295552635 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE ASSEMBLY 6 - 8
• 10603295552703 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE ASSEMBLY 3 - 5
• 10603295552789 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE SHIM 2.0 mm
• 10603295552840 - ATTUNE: 2025-08-05 ATTUNE MAKE TO ORDER POSTERIOR SAW CAPTURE SHIM 3.0 mm
• 10603295552857 - RECLAIM: 2025-08-05 RECLAIM TM MAKE TO ORDER NECK TRIAL SO
• 10603295553465 - RECLAIM: 2025-08-05 RECLAIM TM MAKE TO ORDER NECK TRIAL HO
• 10603295553472 - ATTUNETM: 2025-08-05 ATTUNETM MAKE TO ORDER FEMORAL TRIAL SHIM 1mm THICK