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, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
510(k) Number K030037
Device Name UNIVERSAL TOTAL WRIST SYSTEM
Applicant
Kinetikos Medical, Inc.
6005 Hidden Valley Rd., Suite 180
Carlsbad,  CA  92011
Applicant Contact JOHN SPAMPINATO
Correspondent
Kinetikos Medical, Inc.
6005 Hidden Valley Rd., Suite 180
Carlsbad,  CA  92011
Correspondent Contact JOHN SPAMPINATO
Regulation Number888.3800
Classification Product Code
JWJ  
Date Received01/06/2003
Decision Date 02/05/2003
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
-
-