EBI OsteoGen Implantable Bone Growth Stimulators

FDA Premarket Approval P790005 S067

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.

DeviceEBI OsteoGen Implantable Bone Growth Stimulators
Generic NameStimulator, Invasive Bone Growth
ApplicantEBI, LLC
Date Received2021-01-21
Decision Date2021-02-17
PMAP790005
SupplementS067
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
P790005Original Filing
S067 2021-01-21 30-day Notice
S066 2019-06-21 30-day Notice
S065
S064 2018-04-09 30-day Notice
S063 2018-04-04 30-day Notice
S062 2018-04-02 135 Review Track For 30-day Notice
S061 2018-03-29 30-day Notice
S060 2018-03-09 30-day Notice
S059 2018-03-01 30-day Notice
S058 2018-02-21 30-day Notice
S057 2018-02-13 30-day Notice
S056 2017-05-04 30-day Notice
S055 2017-03-14 30-day Notice
S054 2015-12-17 30-day Notice
S053 2015-11-19 30-day Notice
S052 2015-10-08 30-day Notice
S051 2014-08-20 30-day Notice
S050 2013-09-06 30-day Notice
S049 2013-04-30 30-day Notice
S048 2011-12-21 30-day Notice
S047 2011-04-08 Special (immediate Track)
S046
S045 2008-07-17 30-day Notice
S044 2004-06-09 Normal 180 Day Track
S043 2000-05-30 Real-time Process
S042 2000-04-11 Real-time Process
S041 1998-06-24 Real-time Process
S040 1998-04-09 Real-time Process
S039 1996-10-17 Normal 180 Day Track
S038 1996-03-13 Normal 180 Day Track
S037 1994-11-15 Normal 180 Day Track
S036
S035 1990-08-27 Normal 180 Day Track
S034 1990-01-26 Normal 180 Day Track
S033 1989-03-22 Normal 180 Day Track
S032 1988-03-16 Normal 180 Day Track
S031 1988-02-26 Normal 180 Day Track
S030 1987-06-10 Normal 180 Day Track
S029 1986-11-07 Normal 180 Day Track
S028 1985-10-30
S027 1985-09-06
S026 1985-06-13
S025 1983-11-28
S024 1983-10-04
S023 1983-09-21
S022 1983-08-31
S021 1983-07-20
S020
S019
S018
S017
S016 1983-03-07
S015
S014
S013 1982-04-13
S012 1982-03-08
S011 1982-03-03
S010 1981-09-24
S009 1981-07-29
S008
S007 1981-05-22
S006 1981-04-06
S005
S004 1980-12-16 Normal 180 Day Track
S003 1980-10-27
S002
S001

NIH GUDID Devices

Device IDPMASupp
00812301020065 P790005 032
00812301020065 P790005 032
00812301020119 P790005 045
00812301020027 P790005 045
00812301020034 P790005 045
00812301020041 P790005 045
00812301020058 P790005 045
00812301020072 P790005 045
00812301020102 P790005 045
00812301020119 P790005 045
00812301020010 P790005 045
00812301020027 P790005 045
00812301020034 P790005 045
00812301020041 P790005 045
00812301020058 P790005 045
00812301020072 P790005 045
00812301020102 P790005 045
00812301020010 P790005 045

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.