• 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 orthosis, spondylolisthesis spinal fixation
510(k) Number K100122
Device Name MODIFICATION TO CAPSURE PS SYSTEM
Original Applicant
SPINE WAVE, INC.
three enterprise dr.
suite 210
shelton,  CT  06484
Original Contact roaida rizkallah
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received01/15/2010
Decision Date 02/12/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-