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 Bone Fixation Cerclage, Sublaminar
510(k) Number K160698
Device Name LigaPASS
Applicant
Medicrea International SA
14 Porte Du Grand Lyon
Neyron,  FR 01700
Applicant Contact DAVID RYAN
Correspondent
Medicrea International SA
14 Porte Du Grand Lyon
Neyron,  FR 01700
Correspondent Contact DAVID RYAN
Regulation Number888.3010
Classification Product Code
OWI  
Date Received03/14/2016
Decision Date 09/02/2016
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
-
-