KneeAlign 2 133631

GUDID 10858704006005

KneeAlign 2 Unit

ORTHALIGN, INC.

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• Primary Device ID: 10858704006005
• NIH Device Record Key: dfaf658a-f618-46d3-90f7-18080926324f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KneeAlign 2
• Version Model Number: 133631
• Catalog Number: 133631
• Company DUNS: 023266163
• Company Name: ORTHALIGN, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com
• Phone: 866-582-0879
• Email: CustomerService@orthalign.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Handle with care. Products should be stored in a clean, cool, dry area, away from chemical fumes.
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 101 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858704006008 [Primary]
GS1	10858704006005 [Package]; Contains: 00858704006008; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103829

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-06
• Device Publish Date: 2016-09-23

On-Brand Devices [KneeAlign 2]

• 00810832030393: KneeAlign 2 Instrument Tray Base
• 00810832030386: KneeAlign 2 Instrument Tray Base
• 00810832030263: Tibial Cutting Block, Left, Rapid Traverse
• 00810832030256: Tibial Cutting Block, Right, Rapid Traverse
• 00810832030232: Balancing Application Instrument Kit
• 00810832030225: BRACKET NAV UNIT, KTIS
• 00810832030218: GUIDE,ALIGNMENT,KTIS
• 00810832030201: Tibial Tensor Instrument
• 00810832030195: Femoral Tensor Instrument
• 00810832030058: BASE, TRAY, 10x10, KTIS
• 00858704006800: KneeAlign 2 Instrument Kit
• 00858704006510: Button Cap, Black
• 00858704006503: Button Cap, White
• 00858704006480: Femoral Drill Guide, Neutral
• 00858704006459: Threaded Pin, Headless, 65mm
• 00858704006442: Threaded Pin, Headed, 46mm
• 00858704006435: Pin Driver, Tri-Flat, 3.2mm
• 00858704006428: Pin Driver
• 00858704006411: KneeAlign 2 Instrument Tray Base
• 00858704006404: KneeAlign 2 Inner Tray
• 00858704006398: Instrument Tray Lid
• 00858704006381: KneeAlign 2 Instrument Tray Base
• 00858704006374: 2.5mm Ball Driver
• 00858704006367: KneeAlign 2 Mounting Bracket
• 00858704006343: Distal Guide Assembly
• 00858704006336: MicroBlock Assembly
• 00858704006329: Universal Tibial Cutting Block
• 00858704006312: Reversed Tibial Cutting Block, Right
• 00858704006305: Reversed Tibial Cutting Block, Left
• 00858704006299: KneeAlign 2 Tibial Jig Body
• 00858704006282: KneeAlign 2 Tibial Jig Body, Streamlined
• 00858704006275: KneeAlign 2 Tibial Jig Body
• 00858704006268: Calf Strap
• 00858704006251: Extended Tibial Cutting Block, Right
• 00858704006244: Extended Tibial Cutting Block, Left
• 00858704006237: Adjustable Resection Stylus
• 00858704006220: Shin Spacer
• 00858704006213: Resection Stylus (4-8mm)
• 00858704006206: Resection Stylus (4-8mm)
• 00858704006190: Tibial Cutting Block, Right
• 00858704006183: Tibial Cutting Block, Right
• 00858704006176: Malleolar Probe, Curved
• 00858704006169: Malleolar Probe, Curved
• 00858704006152: Malleolar Probe
• 00858704006145: Malleolar Probe
• 00858704006138: Ankle Tube
• 00858704006121: Ankle Tube
• 00858704006114: Midline Probe
• 00858704006107: Midline Probe
• 00858704006091: Tibial Cutting Block, Left