• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name plate, fixation, bone
510(k) Number K980368
Device Name DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
Original Applicant
DEPUY, INC.
700 orthopaedic dr.
warsaw,  IN  46581 0988
Original Contact lynnette whitaker
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/30/1998
Decision Date 04/14/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-