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
Harvey(R) Surgical Assistant2020-06-18
OrthAlign, Inc.
OrthAlign Plus System2020-04-10
ORTHALIGN, INC.
OrthAlign Plus 4034782020-02-10
ORTHALIGN, INC.
KneeAlign 4016292020-02-10
ORTHALIGN, INC.
OrthAlign Plus 4034722020-02-10
ORTHALIGN, INC.
OrthAlign Plus 403430-102020-02-10
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.
KneeAlign 2 4017702020-02-06
ORTHALIGN, INC.
KneeAlign 2 402064-072020-01-27
ORTHALIGN, INC.
KneeAlign 2 402064-052020-01-27
ORTHALIGN, INC.
OrthAlign Plus 403007-042020-01-27
ORTHALIGN, INC.
OrthAlign Plus 403007-032020-01-27
ORTHALIGN, INC.
OrthAlign Plus 4030012020-01-06
ORTHALIGN, INC.
KneeAlign 2 1336312020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4030012020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4016382020-01-06
ORTHALIGN, INC.
KneeAlign 2 402064-092020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4032032020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4031252020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4031082020-01-06
ORTHALIGN, INC.
KneeAlign 2 402047-032020-01-06
ORTHALIGN, INC.
KneeAlign 2 4020692020-01-06
ORTHALIGN, INC.
KneeAlign 2 4020682020-01-06
ORTHALIGN, INC.
KneeAlign 2 402064-062020-01-06
ORTHALIGN, INC.
KneeAlign 2 402064-042020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-132020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4030012020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4034022020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-112020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-122020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033752020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033442020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033432020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033422020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033412020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033402020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033392020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403218-032020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-102020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033252020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033242020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033232020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033222020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033212020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403218-022020-01-06
ORTHALIGN, INC.
KneeAlign 2 4015002020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403310-1102020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4030012020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403262-1102020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-092020-01-06
ORTHALIGN, INC.
KneeAlign 2 402064-102020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403218-012020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-082020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-072020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-062020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-052020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-022020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-212020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-202020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-192020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4034392020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403430-022020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403430-012020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-182020-01-06
ORTHALIGN, INC.
KneeAlign 2 402100-012020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4033462020-01-06
ORTHALIGN, INC.
OrthAlign Plus 4030012020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-172020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-162020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-152020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403007-142020-01-06
ORTHALIGN, INC.
OrthAlign Plus 403317-1402019-12-31
ORTHALIGN, INC.
OrthAlign Plus 403317-1102019-12-31
ORTHALIGN, INC.
OrthAlign Plus 403300-1402019-12-31
ORTHALIGN, INC.
OrthAlign Plus 403300-1102019-12-31
ORTHALIGN, INC.
OrthAlign Plus 403262-1402019-12-31
ORTHALIGN, INC.
OrthAlign Plus 403430-0112019-12-31
ORTHALIGN, INC.
OrthAlign Plus 403430-072019-12-31
ORTHALIGN, INC.
OrthAlign Plus 403430-052019-12-31
ORTHALIGN, INC.
OrthAlign Plus 403430-042019-12-31
ORTHALIGN, INC.
OrthAlign Plus 403317-0902019-12-31
ORTHALIGN, INC.
OrthAlign Plus 403087-062019-12-30
ORTHALIGN, INC.
OrthAlign Plus 4050012019-12-30
ORTHALIGN, INC.
OrthAlign Plus 4033382019-12-30
ORTHALIGN, INC.
OrthAlign Plus 403008-022019-12-30
ORTHALIGN, INC.
OrthAlign Plus 4034502019-12-30
ORTHALIGN, INC.
OrthAlign Plus 403008-032019-12-30
ORTHALIGN, INC.
OrthAlign Plus 4034682019-12-30
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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