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 K211567
Device Name BiMobile Instruments (for BiMobile Dual Mobility System)
Applicant
Waldemar Link GmbH & Co. KG
Oststraße 4-10
Norderstedt,  DE 22844
Applicant Contact Stefanie Fuchs
Correspondent
LinkBio Corp.
Oststraße 4-10
Norderstedt,  DE 22844
Correspondent Contact Stefani Fuchs
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received05/21/2021
Decision Date 06/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-