Lantern Surgical Assistant (LSA) 402475

GUDID 00810832031512

Torque Driver, 30 in-lbs

ORTHALIGN, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00810832031512
NIH Device Record Key4eec9513-3e57-4f7f-98a1-2520c85779ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameLantern Surgical Assistant (LSA)
Version Model Number402475
Catalog Number402475
Company DUNS023266163
Company NameORTHALIGN, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-582-0879
Emailcustomerservice@orthalign.com
Phone866-582-0879
Emailcustomerservice@orthalign.com
Phone866-582-0879
Emailcustomerservice@orthalign.com
Phone866-582-0879
Emailcustomerservice@orthalign.com
Phone866-582-0879
Emailcustomerservice@orthalign.com
Phone866-582-0879
Emailcustomerservice@orthalign.com
Phone866-582-0879
Emailcustomerservice@orthalign.com
Phone866-582-0879
Emailcustomerservice@orthalign.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810832031512 [Primary]

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810832031512]

Moist Heat or Steam Sterilization


[00810832031512]

Moist Heat or Steam Sterilization


[00810832031512]

Moist Heat or Steam Sterilization


[00810832031512]

Moist Heat or Steam Sterilization


[00810832031512]

Moist Heat or Steam Sterilization


[00810832031512]

Moist Heat or Steam Sterilization


[00810832031512]

Moist Heat or Steam Sterilization


[00810832031512]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-08
Device Publish Date2022-06-30

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

00810832031406Lantern Knee Instrument Set
00810832031444Packaged Assembly, Navigation Unit, LSA Knee
00810832031567Packaged Assembly, Nav Unit, LSA
00810832031543Drill Guide, Balance, LSA
00810832031536Calibration Bracket, Balance, LSA
00810832031512Torque Driver, 30 in-lbs
00810832031505Torque Driver, 25 in-lbs
0081083203149910 X 10, Tray Base, Balance, LSA
00810832031482Femoral Paddle Instrument, Balance, LSA
00810832031475Tibial Paddle Instrument, Balance, LSA
00810832031321Lantern Balance Instrument Set
00810832031963Packaged Assembly, Nav Unit, LSA (JP)
00810832031703Packaged Assembly, Nav Unit, LSA (EU)
00810832032007Reference Sensor (RS), LSA (JP)

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