PHYSIO-STIM BONE GROWTH STIMULATOR

Stimulator, Bone Growth, Non-invasive

FDA Premarket Approval P850007 S022

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

Approval for a modification to the definition of non-union in the labeling (i. E. , a non-union is considered to be established when the fracture site shows no visibly progressive signs of healing).

DevicePHYSIO-STIM BONE GROWTH STIMULATOR
Classification NameStimulator, Bone Growth, Non-invasive
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantOrthofix, Inc.
Date Received1998-06-24
Decision Date1998-08-13
PMAP850007
SupplementS022
Product CodeLOF
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Orthofix, Inc. 3451 Plano Parkway lewisville, TX 75056

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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18257200079032 P850007 032
18257200079049 P850007 032
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18257200079124 P850007 032
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18257200079162 P850007 032
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18257200079018 P850007 032
18257200079001 P850007 032
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18257200078998 P850007 032
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18257200080724 P850007 032
18257200079308 P850007 032
18257200080700 P850007 032
18257200080694 P850007 032
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18257200080670 P850007 032
18257200079315 P850007 032
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18257200079278 P850007 032
18257200123926 P850007 035
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18257200105694 P850007 035
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18257200105687 P850007 035
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18257200131969 P850007 037
18257200131976 P850007 037
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18257200131990 P850007 037
18257200132003 P850007 037
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18257200135912 P850007 037
18257200135929 P850007 037
18257200135936 P850007 037
18257200135943 P850007 037
18257200132010 P850007 037

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