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 K161387
Device Name Mont Blanc and Mont Blanc MIS Spinal Systems
Applicant
Spineway SA
7 Allee Moulin Berger
Ecully,  FR 69130
Applicant Contact NICOLAS ROTH
Correspondent
Rich Jansen, Pharm.D.
11821 Bramble Cove Dr.
Fr. Myers,  FL  33905
Correspondent Contact Rich Jansen, Pharm.D.
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI   OSH  
Date Received05/19/2016
Decision Date 08/04/2016
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
-
-