| Primary Device ID | 00810832031581 |
| NIH Device Record Key | 5a95feb1-d713-4e00-9341-c7e6d70100cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lantern Surgical Assistant (LSA) |
| Version Model Number | 402505 |
| Catalog Number | 402505 |
| 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 | 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 |
| Phone | 866-582-0879 |
| customerservice@orthalign.com | |
| Phone | 866-582-0879 |
| customerservice@orthalign.com | |
| Phone | 866-582-0879 |
| customerservice@orthalign.com | |
| Phone | 866-582-0879 |
| customerservice@orthalign.com | |
| Phone | 866-582-0879 |
| customerservice@orthalign.com | |
| Phone | 866-582-0879 |
| customerservice@orthalign.com | |
| Phone | 866-582-0879 |
| customerservice@orthalign.com | |
| Phone | 866-582-0879 |
| customerservice@orthalign.com | |
| Phone | 866-582-0879 |
| customerservice@orthalign.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810832031581 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810832031581]
Moist Heat or Steam Sterilization
[00810832031581]
Moist Heat or Steam Sterilization
[00810832031581]
Moist Heat or Steam Sterilization
[00810832031581]
Moist Heat or Steam Sterilization
[00810832031581]
Moist Heat or Steam Sterilization
[00810832031581]
Moist Heat or Steam Sterilization
[00810832031581]
Moist Heat or Steam Sterilization
[00810832031581]
Moist Heat or Steam Sterilization
[00810832031581]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-11-20 |
| Device Publish Date | 2023-01-31 |
| 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) |
| 00810832031581 | Driver, .25in Hex, T-Handle |