• 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 intervertebral fusion device with integrated fixation, lumbar
510(k) Number K120031
Device Name CHESAPEAKE SPINAL SYSTEM
Original Applicant
K2M, INC.
751 miller dr., s.e., suite f1
leesburg,  VA  20175
Original Contact nancy giezen
Regulation Number888.3080
Classification Product Code
OVD  
Date Received01/04/2012
Decision Date 03/16/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-