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 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(k) Number K131636
Device Name POLARUS CONNECT
Applicant
Acumed, LLC
5885 NW Cornelius Pass Rd.
Hillsboro,  OR  97124
Applicant Contact BRITTANY CUNNINGHAM
Correspondent
Acumed, LLC
5885 NW Cornelius Pass Rd.
Hillsboro,  OR  97124
Correspondent Contact BRITTANY CUNNINGHAM
Regulation Number888.3030
Classification Product Code
LXT  
Subsequent Product Codes
HRS   HSB  
Date Received06/04/2013
Decision Date 10/10/2013
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
-
-