• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name plate, fixation, bone
510(k) Number K014155
Device Name OPENING/CLOSING WEDGE OSTETOMY PLATES
Applicant
ARTHREX, INC.
2885 south horseshoe dr.
naples,  FL  34104
Applicant Contact ann waterhouse
Correspondent
ARTHREX, INC.
2885 south horseshoe dr.
naples,  FL  34104
Correspodent Contact ann waterhouse
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/19/2001
Decision Date 03/18/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-