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 K993874
Device Name BOFOR REVISION COUP
Applicant
Plus Orthopedics
3550 General Atomics Ct.
Bldg. #15-100
San Diego,  CA  92121
Applicant Contact HARTMUT LOCH
Correspondent
Plus Orthopedics
3550 General Atomics Ct.
Bldg. #15-100
San Diego,  CA  92121
Correspondent Contact HARTMUT LOCH
Regulation Number888.3353
Classification Product Code
LZO  
Date Received11/15/1999
Decision Date 06/05/2000
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
-
-