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 K090299
Device Name BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
Applicant
Aesculap Implant Systems
3773 Corporate Pwky.
Center Valley,  PA  18034
Applicant Contact KATHY A RACOSKY
Correspondent
Aesculap Implant Systems
3773 Corporate Pwky.
Center Valley,  PA  18034
Correspondent Contact KATHY A RACOSKY
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LWJ   MEH  
Date Received02/06/2009
Decision Date 04/24/2009
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
-
-