Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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.
 
DeviceORTHOPAK II BONE GROWTH STIMULATOR
Generic NameStimulator, bone growth, non-invasive
ApplicantEBI, LLC
1 Gatehall Drive
Suite 303
Parsippany, NJ 07054
PMA NumberP850022
Supplement NumberS011
Date Received06/18/1998
Decision Date07/14/1998
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the following modifications:1)The "tombstone" - No part Number a)Change of indication b)Minor grammatical corrections of labeling 2)The Physician Manual-Part Number 380-0001-0001-844 a)Change of indication b)Removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)Minor grammatical corrections of labeling 3)The Patient Manual - Part Number 380-0002-0001-844 a)change of indication b)removed all references to "Snap-on Electrodes" (obsolete) c)Reduced the number of sizes of foam spacers provided from two to one d)Increased the number of leads provided from two to three (20" lead added) e)added the section "Electrode Retainers" (copied from Physician Manual) f)Minor grammatical corrections. The indication change listed above in each section is as follows: removal of the reference to a nine month clinical study time in the approved labels ("A non-union is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visible progressives signs of healing for a minimum of 3 months - no change in fracture callus") and to insert language as suggested in the FDA letter of June 3, 1998 ("A nonunion is considered to be established when the fracture site shows no visible progressive signs of healing"). The device as modified, will be marketed under the trade name OrthoPak(R) and is indicated for treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where width of the defect is less than on-half the width of the defect is less than one-half the width of the bone to be treated.
-
-