BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM

Stimulator, Bone Growth, Non-invasive

FDA Premarket Approval P850022 S026

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

Implementation of a new solder reflow oven in the production of the printed circuit boards for the devices above.

DeviceBIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
Classification NameStimulator, Bone Growth, Non-invasive
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantEBI, LLC
Date Received2015-10-08
Decision Date2015-11-06
PMAP850022
SupplementS026
Product CodeLOF
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
P850022Original Filing
S031 2022-10-28 30-day Notice
S030 2019-09-10 Real-time Process
S029 2018-03-01 30-day Notice
S028 2016-11-08 30-day Notice
S027 2015-12-17 30-day Notice
S026 2015-10-08 30-day Notice
S025 2015-08-10 30-day Notice
S024 2015-04-24 Real-time Process
S023 2014-08-04 30-day Notice
S022 2014-04-10 30-day Notice
S021 2014-02-24 30-day Notice
S020 2013-08-13 Special (immediate Track)
S019
S018 2011-06-13 Real-time Process
S017 2009-09-16 Normal 180 Day Track
S016 2006-02-06 Normal 180 Day Track
S015 2003-09-30 Normal 180 Day Track
S014 2003-04-23 Special (immediate Track)
S013 2001-06-11 Normal 180 Day Track
S012 1999-07-09 Real-time Process
S011 1998-06-18 Real-time Process
S010
S009 1997-03-13 Panel Track
S008 1992-10-05 Normal 180 Day Track
S007 1992-09-24 Normal 180 Day Track
S006 1989-08-25 Normal 180 Day Track
S005 1989-01-26 Normal 180 Day Track
S004 1987-08-04 Normal 180 Day Track
S003 1986-11-17 Special (immediate Track)
S002
S001 1986-09-16 Special (immediate Track)

NIH GUDID Devices

Device IDPMASupp
00812301020188 P850022 006
00880304820845 P850022 006
00880304820852 P850022 006
00812301020201 P850022 008
00812301020195 P850022 008
00812301020249 P850022 017
00812301020232 P850022 017
00812301020225 P850022 017
00812301020218 P850022 017
00812301020416 P850022 017
00887868269318 P850022 017
00887868269301 P850022 017
00887868269295 P850022 017
00887868269288 P850022 017
00887868269271 P850022 017
00812301020256 P850022 017
00812301020263 P850022 017
00812301020409 P850022 017
00812301020393 P850022 017
00812301020386 P850022 017
00812301020379 P850022 017
00812301020362 P850022 017
00812301020355 P850022 017
00812301020348 P850022 017
00812301020331 P850022 017
00812301020324 P850022 017
00812301020317 P850022 017
00812301020300 P850022 017
00812301020294 P850022 017
00812301020287 P850022 017
00812301020270 P850022 017
00887868269264 P850022 017
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