Lantern 403564

GUDID 00810832031895

28mm Liner Registration Trial

Orthalign, Inc.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00810832031895
• NIH Device Record Key: 020686c3-5fb2-4d1b-aef0-cc0bea5ccb9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lantern
• Version Model Number: 403564
• Catalog Number: 403564
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810832031895 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242616

FDA Product Code

• ONN: Intraoperative Orthopedic Joint Assessment Aid

Sterilization

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

[00810832031895]

Moist Heat or Steam Sterilization

[00810832031895]

Moist Heat or Steam Sterilization

[00810832031895]

Moist Heat or Steam Sterilization

[00810832031895]

Moist Heat or Steam Sterilization

[00810832031895]

Moist Heat or Steam Sterilization

[00810832031895]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-23
• Device Publish Date: 2024-12-13

On-Brand Devices [Lantern ]

• 00810832032199: Tray Base, Lantern Hip
• 00810832032168: Adapter Clamp, XL - 0.735" - 1.250"
• 00810832032151: Lantern Hip Instrument Set
• 00810832032137: Adapter Clip, 1/2"
• 00810832032120: Thigh Plate
• 00810832032106: Thigh Mount
• 00810832032076: Adapter Clip, Zimmer G7
• 00810832032069: Adapter Clip, 17.6mm
• 00810832032045: Pelvic Bracket, Lantern Hip
• 00810832032038: Registration Wand
• 00810832032021: Femur Sensor (FS), Lantern Hip
• 00810832032014: Reference Sensor (RS), Lantern Hip
• 00810832031932: 44mm Liner Registration Trial
• 00810832031925: 40mm Liner Registration Trial
• 00810832031918: 36mm Liner Registration Trial
• 00810832031901: 32mm Liner Registration Trial
• 00810832031895: 28mm Liner Registration Trial