Lantern Surgical Assistant (LSA) 406000-01

GUDID 00810832031444

Packaged Assembly, Navigation Unit, LSA Knee

ORTHALIGN, INC.

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• Primary Device ID: 00810832031444
• NIH Device Record Key: c6ac4b35-b473-49ad-ae25-dcfc6cc6f7b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lantern Surgical Assistant (LSA)
• Version Model Number: 406000-01
• Catalog Number: 406000-01
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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
• Phone: 866-582-0879
• Email: customerService@Orthalign.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810832031444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200892

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-04
• Device Publish Date: 2021-10-27

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

• 00810832031406: Lantern Knee Instrument Set
• 00810832031444: Packaged Assembly, Navigation Unit, LSA Knee
• 00810832031567: Packaged Assembly, Nav Unit, LSA
• 00810832031543: Drill Guide, Balance, LSA
• 00810832031536: Calibration Bracket, Balance, LSA
• 00810832031512: Torque Driver, 30 in-lbs
• 00810832031505: Torque Driver, 25 in-lbs
• 00810832031499: 10 X 10, Tray Base, Balance, LSA
• 00810832031482: Femoral Paddle Instrument, Balance, LSA
• 00810832031475: Tibial Paddle Instrument, Balance, LSA
• 00810832031321: Lantern Balance Instrument Set
• 00810832031963: Packaged Assembly, Nav Unit, LSA (JP)
• 00810832031703: Packaged Assembly, Nav Unit, LSA (EU)
• 00810832032007: Reference Sensor (RS), LSA (JP)