PhysioStim®, SpinalStim®

FDA Premarket Approval P850007 S046

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DevicePhysioStim®, SpinalStim®
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantOrthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP850007 Supplement NumberS046 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-03-16
Decision Date2022-06-14
PMAP850007
SupplementS046
Product CodeLOF 
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressOrthofix, Inc.
3451 Plano Parkway
lewisville, TX 75056 PMA NumberP850007 Supplement NumberS046 Date Received03/16/2022 Decision Date06/14/2022 Product Code LOF  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Updates To Orthofix’s Currently Marketed "STIM OnTrack" Mobile Medical Application.

Supplemental Filings

Supplement NumberDateSupplement Type
P850007Original Filing
S046 2022-03-16 Real-time Process
S045
S044 2020-02-26 30-day Notice
S043 2019-09-16 30-day Notice
S042 2019-06-07 30-day Notice
S041 2019-04-15 Real-time Process
S040 2018-09-27 Real-time Process
S039 2018-05-24 Real-time Process
S038 2017-12-07 Real-time Process
S037 2017-08-15 Normal 180 Day Track
S036 2017-03-24 Real-time Process
S035 2016-07-05 Normal 180 Day Track
S034 2015-07-28 30-day Notice
S033 2014-08-01 30-day Notice
S032 2011-10-03 30-day Notice
S031 2011-01-19 Real-time Process
S030 2010-01-21 Normal 180 Day Track No User Fee
S029 2009-08-04 30-day Notice
S028 2009-05-07 Real-time Process
S027 2003-06-04 Normal 180 Day Track
S026 2001-02-01 Normal 180 Day Track
S025 2000-03-13 Normal 180 Day Track
S024 1998-09-22 Real-time Process
S023 1998-07-21 Real-time Process
S022 1998-06-24 Real-time Process
S021 1998-03-03 Normal 180 Day Track
S020 1997-08-25 Normal 180 Day Track
S019 1996-06-12 Normal 180 Day Track
S018 1996-05-07 Normal 180 Day Track
S017 1995-06-16 Normal 180 Day Track
S016 1995-04-05 Normal 180 Day Track
S015
S014 1994-03-03 Normal 180 Day Track
S013 1992-06-23 Normal 180 Day Track
S012 1991-02-21 Normal 180 Day Track
S011 1990-11-26 Normal 180 Day Track
S010 1990-11-13 Normal 180 Day Track
S009
S008 1989-11-22 Normal 180 Day Track
S007 1989-01-24 Normal 180 Day Track
S006 1988-06-06 Panel Track
S005 1988-01-28 Normal 180 Day Track
S004 1987-08-05 Normal 180 Day Track
S003 1987-06-17 Normal 180 Day Track
S002 1986-12-10 Normal 180 Day Track
S001 1986-06-30 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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18257200131969 P850007 037
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18257200131990 P850007 037
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18257200135936 P850007 037
18257200135943 P850007 037
18257200132010 P850007 037

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