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 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K181744
Device Name BI-MENTUM dual mobility system
Applicant
Serf
85 Ave. Des Bruyeres
Decines,  FR 69150
Applicant Contact Jean-Lus Aurelle
Correspondent
Gloster Biomedical International
577 N. Hope Ave.
Santa Barbara,  CA  93110
Correspondent Contact Catherine Gloster
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received07/02/2018
Decision Date 12/11/2018
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
-
-