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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 K030198
Device Name HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
Applicant
HAND INNOVATIONS, INC.
510 stonemont dr.
weston,  FL  33326
Contact richard d bliss, jr.
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/21/2003
Decision Date 04/01/2003
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
-
-