CervicalStim®

FDA Premarket Approval P030034 S017

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

DeviceCervicalStim®
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantOrthofix, Inc.3451 Plano Parkwaylewisville, TX 75056 PMA NumberP030034 Supplement NumberS017 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
PMAP030034
SupplementS017
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 NumberP030034 Supplement NumberS017 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
P030034Original Filing
S017 2022-03-16 Real-time Process
S016
S015 2019-09-16 30-day Notice
S014 2019-04-15 Real-time Process
S013 2018-09-27 Real-time Process
S012 2018-05-24 Real-time Process
S011 2017-12-07 Real-time Process
S010 2017-03-24 Real-time Process
S009 2016-07-05 Normal 180 Day Track
S008 2015-07-28 30-day Notice
S007 2014-08-01 30-day Notice
S006 2011-10-03 30-day Notice
S005 2011-01-19 Real-time Process
S004 2010-01-21 Normal 180 Day Track No User Fee
S003 2009-08-04 30-day Notice
S002 2009-05-07 Real-time Process
S001 2005-02-14 Real-time Process

NIH GUDID Devices

Device IDPMASupp
18257200078936 P030034 006
18257200007158 P030034 006
18257200007165 P030034 006
18257200079094 P030034 006
18257200079100 P030034 006
18257200079131 P030034 006
18257200080816 P030034 006
18257200080823 P030034 006
18257200123919 P030034 009
18257200105663 P030034 009
18257200123933 P030034 009
18257200131440 P030034 009
18257200105649 P030034 009
18257200105632 P030034 009
18257200105656 P030034 009

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