• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceBIOMET EBI BONE HEALING SYSTEM
Classification Namestimulator, bone growth, non-invasive
Generic Namestimulator, bone growth, non-invasive
Applicant
EBI, LLC
399 jefferson road
parsippany, NJ 07054
PMA NumberP790002
Supplement NumberS026
Date Received06/29/2010
Decision Date05/19/2011
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MODIFIED, REDESIGNED, NONINVASIVE PULSED ELECTROMAGNETIC FIELD BONE GROWTH STIMULATOR SYSTEM THAT USES NEW SFLX COILS.
-
-