Lantern Surgical Assistant (HSA) 405152

GUDID 00810832031468

RS LANTERN KNEE (RS20)

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

• Primary Device ID: 00810832031468
• NIH Device Record Key: a232a4d8-38e4-4eaf-9aab-51c4f4ac3809
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lantern Surgical Assistant (HSA)
• Version Model Number: 405152
• Catalog Number: 405152
• 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: false
• Serial Number: true
• 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
• 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
• Phone: 866-582-0879
• Email: customerService@Orthalign.com
• Phone: 866-582-0879
• Email: customerService@Orthalign.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810832031468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200892

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

[00810832031468]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-05
• Device Publish Date: 2021-10-28

On-Brand Devices [Lantern Surgical Assistant (HSA)]

• 00810832031468: RS LANTERN KNEE (RS20)
• 00810832031451: Reference Sensor (RS), LSA