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 orthosis, spondylolisthesis spinal fixation
510(k) Number K122592
Device Name INSTINCT JAVA SYSTEM
Applicant
ZIMMER SPINE
7375 BUSH LAKE ROAD
EDINA,  MN  55439
Applicant Contact ELSA A LINKE
Correspondent
ZIMMER SPINE
7375 BUSH LAKE ROAD
EDINA,  MN  55439
Correspondent Contact ELSA A LINKE
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
MNI   NKB  
Date Received08/24/2012
Decision Date 01/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-