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 Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
510(k) Number K080590
Device Name AOS PROXIMAL HUMERAL PLATE
Applicant
Advanced Orthopaedic Solutions, Inc.
2444 205th St., Unit 5
Torrance,  CA  90501
Applicant Contact PAUL DONER
Correspondent
Advanced Orthopaedic Solutions, Inc.
2444 205th St., Unit 5
Torrance,  CA  90501
Correspondent Contact PAUL DONER
Regulation Number888.3030
Classification Product Code
KTW  
Date Received03/03/2008
Decision Date 05/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-