FDA.reportPublic FDA data

OrthAlign, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30075214803007521480OrthAlign, Inc.1N2026-01-01153 Technology Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810832031994Lantern - Lantern Hip, Navigation Unit, Supine ONLY866-582-0879customerService@Orthalign.com
00810832032182Lantern - LANTERN NAVIGATION UNIT BRACKET, LIGHTWEIGHT866-582-0879customerservice@orthalign.com
00810832032243Lantern - Adapter Clip, 17.6mm Tall866-582-0879customerservice@orthalign.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1010341222815600K242616Lantern® HipONN2024-10-03
1010341428932151K200892Harvey(R) Surgical AssistantOLO2020-06-18
1010341989816349K200642OrthAlign Plus SystemOLO2020-04-10
1010341226120562K172462OrthAlign Plus SystemOLO2017-11-22
1010341031941351K171780OrthAlign Plus SystemOLO2017-07-11
1010341450023047K163379KneeAlign 2 SystemOLO2017-03-02
1010341955711708K162962OrthAlign Plus SystemOLO2017-01-23
1010341704451261K153237OrthAlign Plus SystemOLO2016-03-01
1010341785588416K140331ORTHALIGN PLUS SYSTEMOLO2014-06-10
1010341041859034K130387ORTHOALIGN PLUS SYSTEMOLO2013-11-08
1010341133291039K103829KNEEALIGN SYSTEMOLO2011-04-04
1010341425254374K093998KNEEALIGN SYSTEM WITH REFERENCE SENSOROLO2010-03-22
1010341309037521K091411KNEEALIGN SYSTEMOLO2009-09-25
1010341398756587
1010341782508205
1010341381339289

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLO222020-06-18
ONN12024-10-03

PMN#

GUDID#

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