Primary Device ID | 00810832031536 |
NIH Device Record Key | f35ff3e1-e727-4211-a702-b0a6196bc5b8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lantern Surgical Assistant (LSA) |
Version Model Number | 401788 |
Catalog Number | 401788 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810832031536 [Primary] |
OLO | Orthopedic Stereotaxic Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810832031536]
Moist Heat or Steam Sterilization
[00810832031536]
Moist Heat or Steam Sterilization
[00810832031536]
Moist Heat or Steam Sterilization
[00810832031536]
Moist Heat or Steam Sterilization
[00810832031536]
Moist Heat or Steam Sterilization
[00810832031536]
Moist Heat or Steam Sterilization
[00810832031536]
Moist Heat or Steam Sterilization
[00810832031536]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-08 |
Device Publish Date | 2022-06-30 |
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) |