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/Polymer, Uncemented
510(k) Number K061699
Device Name EXCIA
Applicant
Aesculap, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact LISA M BOYLE
Correspondent
Aesculap AG
Am Aesculap Platz
Tuttlingen, Donau
Baden-Wurttemberg,  DK D-78532
Correspondent Contact Kathy Racosky
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Codes
JDI   LZO  
Date Received06/16/2006
Decision Date 08/18/2006
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
-
-