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

510(k) Premarket Notification

  • 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
Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(k) Number K021695
Device Name EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
Applicant
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Applicant Contact PATRICIA M FLOOD
Correspondent
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Correspondent Contact PATRICIA M FLOOD
Regulation Number888.3030
Classification Product Code
KTT  
Date Received05/22/2002
Decision Date 06/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-