• 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 sacroiliac joint fixation
510(k) Number K130092
Device Name SIMMETRY SACROILIAC JOINT FUSION SYSTEM
Applicant
Zyga Technology, Inc.
700 10TH AVE SOUTH, STE 20
MINNEAPOLIS,  MN  55415 -1745
Applicant Contact Diane Brinza
Correspondent
Zyga Technology, Inc.
700 10TH AVE SOUTH, STE 20
MINNEAPOLIS,  MN  55415 -1745
Correspondent Contact Diane Brinza
Regulation Number888.3040
Classification Product Code
OUR  
Date Received01/15/2013
Decision Date 02/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-