AXIOM® 1293350000

GUDID 1293350000

AXIOM® 3-PEG ALL-POLY PATELLA 35mm

Microport Orthopedics Inc.

Polyethylene patella prosthesis

• Primary Device ID: 1293350000
• NIH Device Record Key: 8ac0ef26-9ba3-42a7-92f4-3699ad984631
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXIOM®
• Version Model Number: 1293350000
• Catalog Number: 1293350000
• 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: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	1293350000 [Direct Marking]
HIBCC	M68412933500001 [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