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 Prosthesis, Wrist, Hemi-, Ulnar
510(k) Number K061146
Device Name SBI ULNAR HEAD IMPLANT
Applicant
SMALL BONE INNOVATIONS INC.
505 PARK AVE., 14TH FLOOR
NEW YORK,  NY  10022
Applicant Contact ROBERT HOEHN
Correspondent
SMALL BONE INNOVATIONS INC.
505 PARK AVE., 14TH FLOOR
NEW YORK,  NY  10022
Correspondent Contact ROBERT HOEHN
Regulation Number888.3810
Classification Product Code
KXE  
Date Received04/25/2006
Decision Date 07/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-