CervicalStim

Stimulator, Bone Growth, Non-invasive

FDA Premarket Approval P030034 S015

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

October 8, 2019the center for devices and radiological health (cdrh) of the food and drug administration (fda) has evaluated your 30-day notice. The 30-day notice requested to modify the manufacturing process for sewing the garment assembly for the orthofix spinalstim model 5212 and modify the manufacturing process to cut, split, and strip the ribbon cable for the orthofix cervicalstim model 5505 and orthofix physiostim models 53xx. Based on the information submitted, fda has determined that submission of a 135-day pma supplement is not required. Therefore, you may distribute your device, incorporating the change described above, upon receipt of this email notification. If you have any questions, please contact the lead reviewer assigned to your submission, habacuc barrera.

DeviceCervicalStim
Classification NameStimulator, Bone Growth, Non-invasive
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantOrthofix, Inc.
Date Received2019-09-16
Decision Date2019-10-08
PMAP030034
SupplementS015
Product CodeLOF
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Orthofix, Inc. 3451 Plano Parkway lewisville, TX 75056

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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