ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR

Stimulator, Bone Growth, Non-invasive

FDA Premarket Approval P910066 S009

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 marketing circular.

DeviceORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
Classification NameStimulator, Bone Growth, Non-invasive
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantDJO, LLC
Date Received1998-07-06
Decision Date1998-07-14
PMAP910066
SupplementS009
Product CodeLOF
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address DJO, LLC 1430 Decision Street vista, CA 92081-8553

Supplemental Filings

Supplement NumberDateSupplement Type
P910066Original Filing
S031 2019-10-23 Real-time Process
S030 2019-07-03 30-day Notice
S029 2018-05-23 30-day Notice
S028 2016-01-19 Special (immediate Track)
S027 2015-06-24 Special (immediate Track)
S026 2012-05-09 Normal 180 Day Track No User Fee
S025 2008-06-12 Normal 180 Day Track
S024 2007-10-12 Real-time Process
S023 2007-02-05 Real-time Process
S022 2006-08-31 Normal 180 Day Track No User Fee
S021 2005-06-01 Real-time Process
S020 2004-09-03 Normal 180 Day Track No User Fee
S019 2004-01-20 Normal 180 Day Track
S018
S017 2002-12-20 Normal 180 Day Track
S016 2001-04-11 Real-time Process
S015 2000-03-31 Real-time Process
S014 2000-02-15 Real-time Process
S013 1999-02-22 Real-time Process
S012 1998-09-22 Real-time Process
S011 1998-08-20 Panel Track
S010
S009 1998-07-06 Real-time Process
S008 1997-12-30 Normal 180 Day Track
S007 1997-11-17 Normal 180 Day Track
S006
S005 1997-02-26 Real-time Process
S004 1996-04-05 Normal 180 Day Track
S003
S002 1996-02-20 Normal 180 Day Track
S001

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.