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 K150283
Device Name Republic Spine Dark Star Spinal System
Applicant
REPUBLIC SPINE, LLC
3200 NE 14TH STREET CAUSEWAY SUITE 250
POMPANO BEACH,  FL  33062
Applicant Contact RUSTY MCCARVER
Correspondent
Wagoner Consulting LLC
PO Box 15729
Wilmington,  NC  28408
Correspondent Contact CHERYL L WAGONER
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received02/05/2015
Decision Date 04/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-