CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic)

FDA Premarket Approval P910066 S031

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

Design changes to the microcontroller and associated changes to the printed circuit board of the cmf bone growth stimulator (ol1000, ol1000 sc, and spinalogic)

DeviceCMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic)
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantDJO, LLC
Date Received2019-10-23
Decision Date2020-01-23
PMAP910066
SupplementS031
Product CodeLOF 
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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

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