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 K130267
Device Name ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
Applicant
SPINEART
COINTRIN 20 ROUTE DE PRE-BOIS
CP1813
GENEVA,  CH 1215
Applicant Contact FRANCK PENNESI
Correspondent
SPINEART
COINTRIN 20 ROUTE DE PRE-BOIS
CP1813
GENEVA,  CH 1215
Correspondent Contact FRANCK PENNESI
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received02/04/2013
Decision Date 05/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-