• 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 screw, fixation, bone
510(k) Number K121682
Model 107-4520, 107-4525, 107-4530, 107-4535, 107-4540, 1074545, 107-4550
Device Name ACTIVE SCREW BONE SCREW
Original Applicant
INTELLIGENT IMPLANT SYSTEMS, LLC
3300 international airport
drive suite 1100
charlotte,  NC  28208
Original Contact michael j nutt
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/07/2012
Decision Date 10/04/2012
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
-
-