PHYSIO/SPINAL-STIM(R) BONE GROWTH STIMULATOR

Stimulator, Bone Growth, Non-invasive

FDA Premarket Approval P850007 S026

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 manufacturing site located at orthofix, inc. , mckinney, texas.

DevicePHYSIO/SPINAL-STIM(R) BONE GROWTH STIMULATOR
Classification NameStimulator, Bone Growth, Non-invasive
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantOrthofix, Inc.
Date Received2001-02-01
Decision Date2001-03-09
PMAP850007
SupplementS026
Product CodeLOF
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonExpress Gmp Supplement
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
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18257200135936 P850007 037
18257200135943 P850007 037
18257200132010 P850007 037

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