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 Posterior Cervical Screw System
510(k) Number K153370
Device Name Caspian OCT/MESA Mini/DENALI Mini Spinal System
Applicant
K2m, Incorporated
751 Miller Dr. SE
Leesburg,  VA  20175
Applicant Contact Nancy Giezen
Correspondent
K2m, Incorporated
751 Miller Dr. Southeast
Leesburg,  VA  20175
Correspondent Contact Nancy Giezen
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received11/23/2015
Decision Date 02/16/2016
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
-
-