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, Spondylolisthesis Spinal Fixation
510(k) Number K081883
Device Name MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM
Applicant
Us Spine
13540 Guild Ave.
Apple Valley,  MN  55124
Applicant Contact RICHARD JANSEN
Correspondent
Us Spine
13540 Guild Ave.
Apple Valley,  MN  55124
Correspondent Contact RICHARD JANSEN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received07/02/2008
Decision Date 09/24/2008
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
-
-