• 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 fastener, fixation, nondegradable, soft tissue
510(k) Number K120356
Device Name NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
Original Applicant
NCS LAB SRL
via pola esterna 4/12
carpi,  IT 41012
Original Contact matteo mantovani
Regulation Number888.3040
Classification Product Code
MBI  
Date Received02/06/2012
Decision Date 12/11/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-