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 K163577
Device Name Ecofit® Hip System
Applicant
Implantcast GmbH
Lueneburger Schanze 26
Buxtehude,  DE 21614
Applicant Contact Juliane Hoeppner
Correspondent
MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS LLC
1050 K Street NW, Suite 1000
WASHINGTON, DC,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3353
Classification Product Code
LZO  
Date Received12/20/2016
Decision Date 09/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-