BIOMET EBI BONE HEALING SYSTEM

Stimulator, Bone Growth, Non-invasive

FDA Premarket Approval P790002 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

Approval for a modified, redesigned, noninvasive pulsed electromagnetic field bone growth stimulator system that uses new sflx coils.

DeviceBIOMET EBI BONE HEALING SYSTEM
Classification NameStimulator, Bone Growth, Non-invasive
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantEBI, LLC
Date Received2010-06-29
Decision Date2011-05-19
PMAP790002
SupplementS026
Product CodeLOF
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address EBI, LLC 399 Jefferson Road parsippany, NJ 07054

Supplemental Filings

Supplement NumberDateSupplement Type
P790002Original Filing
S038 2022-10-28 30-day Notice
S037 2018-03-01 30-day Notice
S036 2016-11-08 30-day Notice
S035 2016-02-11 30-day Notice
S034 2015-12-17 30-day Notice
S033 2015-10-08 30-day Notice
S032 2014-04-10 30-day Notice
S031 2014-02-07 Real-time Process
S030 2013-08-13 Special (immediate Track)
S029 2012-12-04 30-day Notice
S028 2012-05-16 Normal 180 Day Track
S027 2011-08-11 30-day Notice
S026 2010-06-29 Normal 180 Day Track
S025 2007-04-06 Real-time Process
S024
S023 2005-06-17 Real-time Process
S022 2002-04-08 Normal 180 Day Track
S021 1999-11-30 Real-time Process
S020 1998-12-22 Real-time Process
S019 1998-06-24 Real-time Process
S018 1997-02-10 Normal 180 Day Track
S017
S016 1995-06-02 Normal 180 Day Track
S015 1994-07-19 Normal 180 Day Track
S014 1992-09-28 Normal 180 Day Track
S013 1991-10-28 Normal 180 Day Track
S012 1989-08-07 Normal 180 Day Track
S011 1989-04-14 Normal 180 Day Track
S010 1989-03-02 Normal 180 Day Track
S009 1987-06-11 Normal 180 Day Track
S008 1986-10-16 Normal 180 Day Track
S007
S006 1985-04-15
S005
S004 1983-03-02
S003 1982-09-15
S002 1982-07-15
S001 1982-04-01

NIH GUDID Devices

Device IDPMASupp
00812301020492 P790002 026
00812301020508 P790002 026
00812301020515 P790002 026
00812301020522 P790002 026
00812301020539 P790002 026
00812301020546 P790002 026
00812301020577 P790002 026
00812301020584 P790002 026
00812301020591 P790002 026
00812301020607 P790002 026
00812301020645 P790002 026
00812301020638 P790002 026
00812301020621 P790002 026
00812301020614 P790002 026
00812301020478 P790002 028
00812301020461 P790002 028
00812301020454 P790002 028
00812301020447 P790002 028
00812301020676 P790002 028
00812301020485 P790002 028
00812301020553 P790002 028
00812301020560 P790002 028
00812301020652 P790002 028
00812301020669 P790002 028
00812301020430 P790002 028
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