KneeAlign2 402045

GUDID 00858704006350

Femoral Cutting Block

ORTHALIGN, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00858704006350
• NIH Device Record Key: 30ea558f-8fca-43ab-831f-d7a7f68ddc2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KneeAlign2
• Version Model Number: 402045
• Catalog Number: 402045
• Company DUNS: 023266163
• Company Name: ORTHALIGN, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858704006350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103829

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

[00858704006350]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-17
• Device Publish Date: 2016-09-23

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