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 Orthosis, Spinal Pedicle Fixation
510(k) Number K024096
Device Name OPTIMA, SPINAL SYSTEM
Applicant
U&I Corp., America
6132 S. 380 W.,
Murray,  UT  84107 -6988
Applicant Contact PATRICK MOORE
Correspondent
U&I Corp., America
6132 S. 380 W.,
Murray,  UT  84107 -6988
Correspondent Contact PATRICK MOORE
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWQ   MNH  
Date Received12/12/2002
Decision Date 03/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-