• 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 screw, fixation, bone
510(k) Number K121277
Device Name Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
Original Applicant
Z-MEDICAL GMBH & CO. KG
gansacker 38
tuttlingen, baden-wuerttemberg,  DE 78532
Original Contact alexander henninger
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
HTY   JDR  
Date Received04/27/2012
Decision Date 11/07/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-