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.

• Device: CervicalStim
• Classification Name: Stimulator, Bone Growth, Non-invasive
• Generic Name: Stimulator, Bone Growth, Non-invasive
• Applicant: Orthofix, Inc.
• Date Received: 2019-09-16
• Decision Date: 2019-10-08
• PMA: P030034
• Supplement: S015
• Product Code: LOF
• Advisory Committee: Orthopedic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Orthofix, Inc. 3451 Plano Parkway lewisville, TX 75056

Supplemental Filings

Supplement Number	Date	Supplement Type
P030034		Original 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 ID	PMA	Supp
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