Lantern Surgical Assistant 403578

GUDID 00810832032144

Adapter Clamp, Small 0.325”-0.500”

Orthalign, Inc.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00810832032144
• NIH Device Record Key: 7d3bbad4-e14a-499d-8979-e00cb079ec00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lantern Surgical Assistant
• Version Model Number: 403578
• Catalog Number: 403578
• 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	00810832032144 [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

[00810832032144]

Moist Heat or Steam Sterilization

[00810832032144]

Moist Heat or Steam Sterilization

[00810832032144]

Moist Heat or Steam Sterilization

[00810832032144]

Moist Heat or Steam Sterilization

[00810832032144]

Moist Heat or Steam Sterilization

[00810832032144]

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 Surgical Assistant]

• 00810832031635: JOURNEY II SIZES 9-10 DRILL PLATE
• 00810832031628: JOURNEY II SIZES 7-8 DRILL PLATE
• 00810832031611: JOURNEY II SIZES 5-6 DRILL PLATE
• 00810832031604: JOURNEY II SIZES 3-4 DRILL PLATE
• 00810832031598: JOURNEY II SIZES 1-2 DRILL PLATE
• 00810832031864: Drill Plate, United Orthopedics, Size 1-7
• 00810832031857: Drill Plate, Lima Physica, Size 1-10
• 00810832031840: Drill Plate, Globus GENflex2, Posterior Ref Size 1-6
• 00810832031819: Microport Evolution PR, Balance Drill Plate, Sizes 5-7
• 00810832031802: Microport Evolution PR, Balance Drill Plate, Sizes 1-4
• 00810832031789: Microport Evolution DCF, Balance Drill Plate, Size 8
• 00810832031772: Microport Evolution DCF, Balance Drill Plate, Size 7
• 00810832031765: Microport Evolution DCF, Balance Drill Plate, Size 6
• 00810832031758: Microport Evolution DCF, Balance Drill Plate, Size 5
• 00810832031741: Microport Evolution DCF, Balance Drill Plate, Size 4
• 00810832031734: Microport Evolution DCF, Balance Drill Plate, Size 3
• 00810832031727: Microport Evolution DCF, Balance Drill Plate, Size 2
• 00810832031710: Microport Evolution DCF, Balance Drill Plate, Size 1
• 00810832031697: Microport Advance, Balance Drill Plate, Size 6
• 00810832031680: Microport Advance, Balance Drill Plate, Size 5
• 00810832031673: Microport Advance, Balance Drill Plate, Size 4
• 00810832031666: Microport Advance, Balance Drill Plate, Size 3
• 00810832031659: Microport Advance, Balance Drill Plate, Size 2
• 00810832031642: Microport Advance, Balance Drill Plate, Size 1
• 00810832032144: Adapter Clamp, Small 0.325”-0.500”