AXIOM® 1293290000

GUDID 1293290000

AXIOM® 3-PEG ALL-POLY PATELLA 29mm

Microport Orthopedics 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: 1293290000
• NIH Device Record Key: 00f78dcf-5fe6-470c-a107-e61ec5e7fde4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXIOM®
• Version Model Number: 1293290000
• Catalog Number: 1293290000
• 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: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter
• Outer Diameter: 29 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	1293290000 [Direct Marking]
HIBCC	M68412932900001 [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: 2015-10-22

On-Brand Devices [AXIOM® ]

• 1410RT8500: AXIOM® PSK FEMORAL 85mm RIGHT NON-POROUS
• 1410RT8000: AXIOM® PSK FEMORAL 80mm RIGHT NON-POROUS
• 1410RT7500: AXIOM® PSK FEMORAL 75mm RIGHT NON-POROUS
• 1410RT7000: AXIOM® PSK FEMORAL 70mm RIGHT NON-POROUS
• 1410RT6500: AXIOM® PSK FEMORAL 65mm RIGHT NON-POROUS
• 1410RT6000: AXIOM® PSK FEMORAL 60mm RIGHT NON-POROUS
• 1410LT8500: AXIOM® PSK FEMORAL 85mm LEFT NON-POROUS
• 1410LT7000: AXIOM® PSK FEMORAL 70mm LEFT NON-POROUS
• 1409LT6500: AXIOM® PSK FEMORAL 65 mm LEFT POROUS
• 1331851400: AXIOM® DUAL DOME ALL POLY TIBIA 85mm X 14mm A/P CURVED
• 1331751700: AXIOM® DUAL DOME ALL POLY TIBIA 75mm X 17mm A/P CURVED
• 1281RT8500: PRIMARY FEMORAL 85mm RIGHT NONPOROUS
• 1281RT8000: PRIMARY FEMORAL 80mm RIGHT NONPOROUS
• 1281RT7500: PRIMARY FEMORAL 75mm RIGHT NONPOROUS
• 1281RT7000: PRIMARY FEMORAL 70mm RIGHT NONPOROUS
• 1281RT6500: PRIMARY FEMORAL 65mm RIGHT NONPOROUS
• 1281RT6000: PRIMARY FEMORAL 60mm RIGHT NONPOROUS
• 1281RT5500: PRIMARY FEMORAL 55mm RIGHT NONPOROUS
• 1281LT8500: PRIMARY FEMORAL 85mm LEFT NONPOROUS
• 1281LT8000: PRIMARY FEMORAL 80mm LEFT NONPOROUS
• 1281LT7500: PRIMARY FEMORAL 75mm LEFT NONPOROUS
• 1281LT7000: PRIMARY FEMORAL 70mm LEFT NONPOROUS
• 1281LT6500: PRIMARY FEMORAL 65mm LEFT NONPOROUS
• 1281LT6000: PRIMARY FEMORAL 60mm LEFT NONPOROUS
• 1281LT5500: PRIMARY FEMORAL 55mm LEFT NONPOROUS
• 1293440000: AXIOM® 3-PEG ALL-POLY PATELLA 44mm
• 1293410000: AXIOM® 3-PEG ALL-POLY PATELLA 41mm
• 1293380000: AXIOM® 3-PEG ALL-POLY PATELLA 38mm
• 1293350000: AXIOM® 3-PEG ALL-POLY PATELLA 35mm
• 1293320000: AXIOM® 3-PEG ALL-POLY PATELLA 32mm
• 1293290000: AXIOM® 3-PEG ALL-POLY PATELLA 29mm