KneeAlign 401629

GUDID 00858704006527

Resection Guide, 1.27mm Slot Width

ORTHALIGN, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00858704006527
• NIH Device Record Key: ba165f5b-0361-4d17-892c-500a338342fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KneeAlign
• Version Model Number: 401629
• Catalog Number: 401629
• Company DUNS: 023266163
• Company Name: ORTHALIGN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Dimensions

• Width: 1.27 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858704006527 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00858704006527]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-10
• Device Publish Date: 2020-01-31

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