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

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 plate, fixation, bone
510(k) Number K083364
Device Name 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact SUZANA OTANO
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Correspondent Contact SUZANA OTANO
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/13/2008
Decision Date 12/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-