• 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 interlaminal
510(k) Number K121808
Device Name CASIAN, 3.5/4.5 CONNECTORS
Original Applicant
K2M, INC.
751 miller dr.,se
leesburg,  VA  20175
Original Contact nancy giezen
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received06/20/2012
Decision Date 07/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-