AMK 148829025

GUDID 10603295039600

AMK TOTAL KNEE SYSTEM ALL POLY PATELLA COOKIE CUTTER DOME 10mm x 40mm

DEPUY ORTHOPAEDICS, INC.

Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis

• Primary Device ID: 10603295039600
• NIH Device Record Key: 3d3c9b42-975a-465a-a478-2625d591e02a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMK
• Version Model Number: 1488-29-025
• Catalog Number: 148829025
• 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	10603295039600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873197

FDA Product Code

• JDB: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

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