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 Spinous Process Plate
510(k) Number K130066
Device Name SPECTRUM SPINE SPINOUS PROCESS DEVICE
Applicant
Spectrum Spine IP Holdings, LLC
13540 Guild Ave.
Apple Valley,  MN  55124
Applicant Contact RICH JANSEN
Correspondent
Spectrum Spine IP Holdings, LLC
13540 Guild Ave.
Apple Valley,  MN  55124
Correspondent Contact RICH JANSEN
Regulation Number888.3050
Classification Product Code
PEK  
Date Received01/10/2013
Decision Date 11/12/2013
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
-
-