SpF Implantable Spinal Fusion Stimulators

FDA Premarket Approval P850035 S056

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

To qualify and approve an alternate, proposed supplier to provide thermoformed petg packaging trays and lids utilized in the final sterile pack assembly of ebi osteogen surgically implantable bone growth stimulators and spf implantable spinal fusion stimulators.

DeviceSpF Implantable Spinal Fusion Stimulators
Generic NameStimulator, Invasive Bone Growth
ApplicantEBI, LLC
Date Received2021-01-21
Decision Date2021-02-17
PMAP850035
SupplementS056
Product CodeLOE 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address EBI, LLC 399 Jefferson Road parsippany, NJ 07054

Supplemental Filings

Supplement NumberDateSupplement Type
P850035Original Filing
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
00812301020096 P850035 032
00812301020089 P850035 032
00812301020133 P850035 033
00812301020126 P850035 033
00812301020133 P850035 033
00812301020126 P850035 033

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