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 K060294
Device Name DIAPHYSEAL PLATE
Applicant
HAND INNOVATIONS, LLC.
8905 SW 87TH AVENUE,
SUITE 220
MIAMI LAKES,  FL  33176
Applicant Contact ERNESTO HERNANDEZ
Correspondent
HAND INNOVATIONS, LLC.
8905 SW 87TH AVENUE,
SUITE 220
MIAMI LAKES,  FL  33176
Correspondent Contact ERNESTO HERNANDEZ
Regulation Number888.3030
Classification Product Code
HRS  
Date Received02/06/2006
Decision Date 03/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-