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 K063020
Device Name INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM
Applicant
INTAI TECHNOLOGY INC.
4230 EAST AIRPORT DRIVE
SUITE 110
ONTARIO,  CA  91761
Applicant Contact PIEWEN LIN
Correspondent
INTAI TECHNOLOGY INC.
4230 EAST AIRPORT DRIVE
SUITE 110
ONTARIO,  CA  91761
Correspondent Contact PIEWEN LIN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   KTT  
Date Received10/02/2006
Decision Date 12/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-