• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name cement, bone, vertebroplasty
510(k) Number K122175
Model 12C20HO, 13C2040
Device Name MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
Original Applicant
TECRES SPA
7 trail house court
rockville,  MD  20850
Original Contact christine brauer, ph.d.
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
LOD  
Date Received07/23/2012
Decision Date 03/28/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-