Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name plate, fixation, bone
510(k) Number K990094
Device Name KMI WRIST FUSION SYSTEM
Applicant
KINETIKOS MEDICAL, INC.
4115 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Applicant Contact MICHAEL COLLINS
Correspondent
KINETIKOS MEDICAL, INC.
4115 SORRENTO VALLEY BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact MICHAEL COLLINS
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/12/1999
Decision Date 02/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-