CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM

Stimulator, Bone Growth, Non-invasive

FDA Premarket Approval P030034

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the cervical-stim model 505l cervical fusion system. The cervical-stim model 505l cervical fusion system is a non-invasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion.

DeviceCERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM
Classification NameStimulator, Bone Growth, Non-invasive
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantOrthofix, Inc.
Date Received2003-08-22
Decision Date2004-12-23
Notice Date2005-01-21
PMAP030034
SupplementS
Product CodeLOF
Docket Number05M-0028
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address Orthofix, Inc. 3451 Plano Parkway lewisville, TX 75056
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

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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