AMK 148495025

GUDID 10603295039372

AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 9.5mm x 38mm

DEPUY ORTHOPAEDICS, INC.

Polyethylene patella prosthesis

• Primary Device ID: 10603295039372
• NIH Device Record Key: 420f0ae7-9569-4ed9-b7b8-c8d3bb808220
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMK
• Version Model Number: 1484-95-025
• Catalog Number: 148495025
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295039372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972643

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

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: 2021-02-05
• Device Publish Date: 2015-09-24

On-Brand Devices [AMK]

• 10603295039624: AMK TOTAL KNEE SYSTEM ALL POLY PATELLA COOKIE CUTTER DOME 9.5mm x 38mm
• 10603295039617: AMK TOTAL KNEE SYSTEM ALL POLY PATELLA COOKIE CUTTER DOME 8.5mm x 34mm
• 10603295039600: AMK TOTAL KNEE SYSTEM ALL POLY PATELLA COOKIE CUTTER DOME 10mm x 40mm
• 10603295039594: AMK TOTAL KNEE SYSTEM ALL POLY PATELLA COOKIE CUTTER DOME 7.5mm x 30mm
• 10603295039389: AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 10mm x 40mm
• 10603295039372: AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 9.5mm x 38mm
• 10603295039365: AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 9mm x 36mm
• 10603295039358: AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 8.5mm x 34mm
• 10603295039341: AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 7.5mm x 30mm
• 10603295039334: AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 7.5mm x 26mm
• 10603295125969: AMK FIXATION PIN .125in x 3in