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 Thoracolumbosacral Pedicle Screw System
510(k) Number K181821
Device Name MOSS VRS Spinal System
Applicant
Biedermann Motech GmbH & Co. KG
Bertha-Von-Suttner-Strasse 23
Villingen-Schwenningen,  DE 78054
Applicant Contact Gerd Federle
Correspondent
Biedermann Motech GmbH & Co. KG
Bertha-Von-Suttner-Strasse 23
Villingen-Schwenningen,  DE 78054
Correspondent Contact Gerd Federle
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/09/2018
Decision Date 09/13/2018
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
-
-