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 K172235
Device Name CoreHip® System
Applicant
Aesculap Implants Systems, LLC
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact Paul Amudala
Correspondent
Aesculap Implants Systems, LLC
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact Paul Amudala
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LWJ  
Date Received07/25/2017
Decision Date 03/28/2018
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
-
-