• 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 | 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 appliance, fixation, spinal intervertebral body
510(k) Number K121862
Device Name REX ANTERIOR CERVICAL PLATE SYSTEM
Original Applicant
DIO MEDICAL CO., LTD.
325 n. puente st
unit b
brea,  CA  92821
Original Contact april lee
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/26/2012
Decision Date 10/31/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-