SpF Implantable Spinal Fusion Stimulators

FDA Premarket Approval P850035 S057

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

DeviceSpF Implantable Spinal Fusion Stimulators
Generic NameStimulator, Invasive Bone Growth
ApplicantEBI, LLC1 Gatehall Drivesuite 303parsippany, NJ 07054 PMA NumberP850035 Supplement NumberS057 Date Received05/27/2022 Decision Date08/25/2022 Product Code LOE  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-27
Decision Date2022-08-25
PMAP850035
SupplementS057
Product CodeLOE 
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressEBI, LLC
1 Gatehall Drive
suite 303
parsippany, NJ 07054 PMA NumberP850035 Supplement NumberS057 Date Received05/27/2022 Decision Date08/25/2022 Product Code LOE  Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Executing An Ethylene Oxide Terminal Sterilization Process Validation To Align With Applicable Requirements Of ISO 11135:2014 (14-529).

Supplemental Filings

Supplement NumberDateSupplement Type
P850035Original Filing
S057 2022-05-27 Real-time Process
S056 2021-01-21 30-day Notice
S055 2019-06-21 30-day Notice
S054
S053 2018-04-09 30-day Notice
S052 2018-04-04 30-day Notice
S051 2018-04-02 135 Review Track For 30-day Notice
S050 2018-03-29 30-day Notice
S049 2018-03-09 30-day Notice
S048 2018-03-01 30-day Notice
S047 2018-02-21 30-day Notice
S046 2018-02-13 30-day Notice
S045 2017-05-04 30-day Notice
S044 2017-03-14 30-day Notice
S043 2016-10-31 Special (immediate Track)
S042 2016-02-19 Special (immediate Track)
S041 2015-12-17 30-day Notice
S040 2015-11-19 30-day Notice
S039 2015-10-08 30-day Notice
S038 2014-08-20 30-day Notice
S037
S036 2013-09-06 30-day Notice
S035 2013-04-30 30-day Notice
S034 2012-02-01 30-day Notice
S033 2008-07-22 Normal 180 Day Track No User Fee
S032 2008-07-17 30-day Notice
S031 2007-02-23 Real-time Process
S030 2004-06-09 Normal 180 Day Track
S029 2002-06-13 Normal 180 Day Track
S028 2000-05-30 Real-time Process
S027
S026
S025 2000-03-31 Normal 180 Day Track
S024 1998-07-06 Normal 180 Day Track
S023 1998-04-09 Real-time Process
S022 1997-04-08 Real-time Process
S021 1996-10-17 Normal 180 Day Track
S020 1996-07-19 Normal 180 Day Track
S019 1996-03-13 Normal 180 Day Track
S018 1995-12-08 Special (immediate Track)
S017 1994-11-22 Normal 180 Day Track
S016 1994-11-15 Normal 180 Day Track
S015
S014
S013 1992-03-27 Normal 180 Day Track
S012 1991-05-10 Normal 180 Day Track
S011
S010 1990-10-25 Normal 180 Day Track
S009
S008 1990-05-31 Normal 180 Day Track
S007 1988-12-16 Normal 180 Day Track
S006 1988-10-12 Normal 180 Day Track
S005 1988-04-18 Normal 180 Day Track
S004 1988-03-16 Normal 180 Day Track
S003 1988-02-26 Normal 180 Day Track
S002 1988-01-15 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00812301020096 P850035 032
00812301020089 P850035 032
00812301020133 P850035 033
00812301020126 P850035 033

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