• 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 intervertebral fusion device with bone graft, cervical
510(k) Number K121741
Device Name 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
Original Applicant
4-WEB, INC.
13540 guild ave.
apple valley,  MN  55124
Original Contact rich jansen, pharm, d.
Regulation Number888.3080
Classification Product Code
ODP  
Date Received06/15/2012
Decision Date 10/18/2012
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
-
-