Axiom 1285320000

GUDID 1285320000

AXIOM® CENTRAL PEG POLY PATELLA 32mm

Microport Orthopedics Inc.

Polyethylene patella prosthesis

• Primary Device ID: 1285320000
• NIH Device Record Key: e401e973-a0fc-4e3c-828d-e8bb9776f07e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axiom
• Version Model Number: 1285320000
• Catalog Number: 1285320000
• Company DUNS: 079118736
• Company Name: Microport Orthopedics 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: true
• 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: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com
• Phone: 1-866-872-0211
• Email: customerservice2@ortho.microport.com

Device Dimensions

• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter
• Outer Diameter: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	1285320000 [Direct Marking]
HIBCC	M68412853200001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894334

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: 2015-10-20

On-Brand Devices [Axiom]

• 1283100000: AXIOM® AUGMENT SCREW KIT 5mm & 10mm
• 1279008500: AXIOM® MODULAR TIBIAL BASE 85mm W/ HOLE PLUGS NONPOROUS
• 1279008000: AXIOM® MODULAR TIBIAL BASE 80mm W/ HOLE PLUGS NONPOROUS
• 1279007500: AXIOM® MODULAR TIBIAL BASE 75mm W/ HOLE PLUGS NONPOROUS
• 1279007000: AXIOM® MODULAR TIBIAL BASE 70mm W/ HOLE PLUGS NONPOROUS
• 1279006500: AXIOM® MODULAR TIBIAL BASE 65mm W/ HOLE PLUGS NONPOROUS
• 1279006000: AXIOM® MODULAR TIBIAL BASE 60mm W/ HOLE PLUGS NONPOROUS
• 1277008000: AXIOM® ACL RETAINING TIB BASE 80mm NONPOROUS W/ SCREW HOLES
• 1277007500: AXIOM® ACL RETAINING TIB BASE 75mm NONPOROUS W/ SCREW HOLES
• 1277007000: AXIOM® ACL RETAINING TIB BASE 70mm NONPOROUS W/ SCREW HOLES
• 1277006500: AXIOM® ACL RETAINING TIB BASE 65mm NONPOROUS W/ SCREW HOLES
• 1274008500: AXIOM® PRIMARY TIBIAL BASE 85mm NONPOROUS W/ SCREW HOLES
• 1274008000: AXIOM® PRIMARY TIBIAL BASE 80mm NONPOROUS W/ SCREW HOLES
• 1274007500: AXIOM® PRIMARY TIBIAL BASE 75mm NONPOROUS W/ SCREW HOLES
• 1274007000: AXIOM® PRIMARY TIBIAL BASE 70mm NONPOROUS W/ SCREW HOLES
• 1274006500: AXIOM® PRIMARY TIBIAL BASE 65mm NONPOROUS W/ SCREW HOLES
• 1270008500: AXIOM® PRIMARY TIBIAL BASE 85mm NONPOROUS NO SCREW HOLES
• 1270008000: AXIOM® PRIMARY TIBIAL BASE 80mm NONPOROUS NO SCREW HOLES
• 1270007500: AXIOM® PRIMARY TIBIAL BASE 75mm NONPOROUS NO SCREW HOLES
• 1270007000: AXIOM® PRIMARY TIBIAL BASE 70mm NONPOROUS NO SCREW HOLES
• 1270006500: AXIOM® PRIMARY TIBIAL BASE 65mm NONPOROUS NO SCREW HOLES
• 1270006000: AXIOM® PRIMARY TIBIAL BASE 60mm NONPOROUS NO SCREW HOLES
• 1270005500: AXIOM® PRIMARY TIBIAL BASE 55mm NONPOROUS NO SCREW HOLES
• 1279189000: AXIOM® MODULAR STEM EXTENSION 18 x 90mm
• 1279181800: AXIOM® MODULAR STEM EXTENSION 18 X 180mm
• 1279169000: AXIOM® MODULAR STEM EXTENSION 16 X 90mm
• 1279161800: AXIOM® MODULAR STEM EXTENSION 16 X 180mm
• 1279149000: AXIOM® MODULAR STEM EXTENSION 14 X 90mm
• 1279141800: AXIOM® MODULAR STEM EXTENSION 14 X 180mm
• 1279129000: AXIOM® MODULAR STEM EXTENSION 12 X 90mm
• 1279121800: AXIOM® MODULAR STEM EXTENSION 12 X 180mm
• 1279109000: AXIOM® MODULAR STEM EXTENSION 10 X 90mm
• 1285410000: AXIOM® CENTRAL PEG POLY PATELLA 41mm
• 1285380000: AXIOM® CENTRAL PEG POLY PATELLA 38mm
• 1285350000: AXIOM® CENTRAL PEG POLY PATELLA 35mm
• 1285320000: AXIOM® CENTRAL PEG POLY PATELLA 32mm
• 1285290000: AXIOM® CENTRAL PEG POLY PATELLA 29mm