Orthalign Inc

FDA Filings

This page includes the latest FDA filings for Orthalign Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3007521480
FEI Number3007521480
NameOrthAlign, Inc.
Owner & OperatorOrthAlign, Inc
Contact Address120 Columbia Suite 500
Aliso Viejo CA 92656 US
Official Correspondent
  • Karyl Haskell
  • x-952-2215343-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address120 Columbia Suite 500
Aliso Viejo, CA 92656 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 405204-KA2023-11-29
ORTHALIGN, INC.
Lantern Surgical Assistant 4025432023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 4025422023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 4025412023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402532-022023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402532-012023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402528-082023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402528-072023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402528-062023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402528-052023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402528-042023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402528-032023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402528-022023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402528-012023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402519-062023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402519-052023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402519-042023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402519-032023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402519-022023-09-11
ORTHALIGN, INC.
Lantern Surgical Assistant 402519-012023-09-11
ORTHALIGN, INC.
OrthAlign Plus 403001-08-US2023-08-03
ORTHALIGN, INC.
OrthAlign Plus 403001-07-US2023-08-03
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 406000-02-JP2023-06-13
ORTHALIGN, INC.
OrthAlign Plus 403001-08-JP2023-06-13
ORTHALIGN, INC.
OrthAlign Plus 403001-07-JP2023-06-13
ORTHALIGN, INC.
OrthAlign Plus 403001-08-CE2023-06-13
ORTHALIGN, INC.
OrthAlign Plus 403001-07-CE2023-06-13
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 406000-02-CE2023-06-13
ORTHALIGN, INC.
Lantern Surgical Assistant 4025112023-03-21
ORTHALIGN, INC.
Lantern Surgical Assistant 4025102023-03-21
ORTHALIGN, INC.
Lantern Surgical Assistant 4025092023-03-21
ORTHALIGN, INC.
Lantern Surgical Assistant 4025082023-03-21
ORTHALIGN, INC.
Lantern Surgical Assistant 4025072023-03-21
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 406000-022022-07-08
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 4024732022-07-08
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 4017882022-07-08
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 4024752022-07-08
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 4024742022-07-08
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 4024772022-07-08
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 4024722022-07-08
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 4017852022-07-08
ORTHALIGN, INC.
Lantern Surgical Assistant (HSA) 4052042022-07-08
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 405185-012022-07-08
ORTHALIGN, INC.
OrthAlign Plus 402066-72022-06-01
ORTHALIGN, INC.
OrthAlign Plus 2022-03-21
ORTHALIGN, INC.
OrthAlign Plus 2022-03-21
ORTHALIGN, INC.
OrthAlign Plus 2022-03-21
ORTHALIGN, INC.
Lantern Surgical Assistant (HSA) 4051522021-11-05
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 406000-012021-11-04
ORTHALIGN, INC.
Lantern Surgical Assistant (LSA) 406001-012021-10-22
ORTHALIGN, INC.
KneeAlign 2 133631-012021-07-07
ORTHALIGN, INC.
OrthAlign Plus 403001-082021-07-07
ORTHALIGN, INC.
OrthAlign Plus 403001-072021-07-07
ORTHALIGN, INC.
OrthAlign Plus 4024672021-07-01
ORTHALIGN, INC.
OrthAlign Plus 4024632021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4022032021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4024462021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4022002021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021622021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021612021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4017772021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021552021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021542021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021532021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021522021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021502021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021492021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021482021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021472021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021462021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021452021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021442021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4021422021-03-25
ORTHALIGN, INC.
OrthAlign Plus 4017602021-03-25
ORTHALIGN, INC.
OrthAlign Plus 403430-122021-03-08
ORTHALIGN, INC.
OrthAlign Plus 403007-222021-02-26
ORTHALIGN, INC.
OrthAlign Plus 4017532021-02-19
ORTHALIGN, INC.
OrthAlign Plus 4034982020-10-20
ORTHALIGN, INC.
OrthAlign Plus 4034842020-10-20
ORTHALIGN, INC.
OrthAlign Plus 402100-022020-10-12
ORTHALIGN, INC.
Harvey Surgical Assistant (HSA) 4050812020-09-24
ORTHALIGN, INC.
Harvey Surgical Assistant (HSA) 4050802020-09-24
ORTHALIGN, INC.
Harvey Surgical Assistant (HSA) 4050552020-09-24
ORTHALIGN, INC.
Harvey Surgical Assistant (HSA) 4050622020-09-24
ORTHALIGN, INC.
Harvey Surgical Assistant (HSA) 4021272020-09-24
OrthAlign Inc
Harvey(R) Surgical Assistant2020-06-18
OrthAlign, Inc.
OrthAlign Plus System2020-04-10
ORTHALIGN, INC.
OrthAlign Plus 403430-092020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4034862020-02-10
ORTHALIGN, INC.
OrthAlign Plus 403430-082020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4034142020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4034802020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4034832020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4017492020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4017462020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4017452020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4017482020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4017472020-02-10
ORTHALIGN, INC.
KneeAlign 2 4017442020-02-10
ORTHALIGN, INC.
KneeAlign 2 4017432020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4034692020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4034772020-02-10
OrthAlign, Inc. [OrthAlign, Inc]
OrthAlign Plus System2017-11-27
OrthAlign, Inc.
OrthAlign Plus System2017-11-22
OrthAlign, Inc. [OrthAlign, Inc]
OrthAlign Plus System2017-09-18
OrthAlign, Inc.
OrthAlign Plus System2017-07-11
OrthAlign, Inc. [OrthAlign, Inc]
KneeAlign 2 System2017-03-23
OrthAlign, Inc. [OrthAlign, Inc]
OrthAlign Plus System2017-03-23
OrthAlign, Inc.
KneeAlign 2 System2017-03-02
OrthAlign, Inc.
OrthAlign Plus System2017-01-23
OrthAlign, Inc. [OrthAlign, Inc]
OrthAlign Plus System2016-09-09
OrthAlign, Inc.
OrthAlign Plus System2016-03-01
OrthAlign, Inc. [OrthAlign, Inc]
Orthopedic Template2015-05-01
OrthAlign, Inc. [OrthAlign, Inc]
OrthAlign Plus2014-12-15
ORTHALIGN, INC
ORTHALIGN PLUS SYSTEM2014-06-10
OrthAlign, Inc. [OrthAlign, Inc]
Torque Driver2014-04-08
OrthAlign, Inc. [OrthAlign, Inc]
Resection Guide2014-04-08
OrthAlign, Inc. [OrthAlign, Inc]
Pin Driver2014-04-08
OrthAlign, Inc. [OrthAlign, Inc]
Hex Driver2014-04-08
OrthAlign, Inc. [OrthAlign, Inc]
Femur Plate2014-04-08
OrthAlign, Inc. [OrthAlign, Inc]
Femoral Drill Guide2014-04-08
OrthAlign, Inc. [OrthAlign, Inc]
Bicruciate Visual Guide2014-04-08
OrthAlign, Inc. [OrthAlign, Inc]
Ball Driver2014-04-08
OrthAlign, Inc. [OrthAlign, Inc]
Adapter Socket Driver2014-04-08
OrthAlign, Inc. [OrthAlign, Inc]
KneeAlign 22014-03-25
OrthAlign, Inc. [OrthAlign, Inc]
OrthAlign Plus2013-12-11
OrthAlign, Inc. [OrthAlign, Inc]
HipAlign2013-12-11
ORTHALIGN, INC
ORTHOALIGN PLUS SYSTEM2013-11-08
OrthAlign, Inc. [OrthAlign, Inc]
KneeAlign System2011-11-30
ORTHALIGN, INC
KNEEALIGN SYSTEM2011-04-04
ORTHALIGN, INC
KNEEALIGN SYSTEM WITH REFERENCE SENSOR2010-03-22
OrthAlign, Inc. [OrthAlign, Inc]
KneeAlign System2010-01-05
ORTHALIGN, INC
KNEEALIGN SYSTEM2009-09-25

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