• 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 K153381
Device Name Corin Metafix Hip Stem
Applicant
Corin USA Limited
5670 W. Cypress St., Suite C
tampa,  FL  33607
Applicant Contact rachel king
Correspondent
Corin USA Limited
5670 W. Cypress St., Suite C
tampa,  FL  33607
Correspondent Contact rachel king
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWL   KWY   MEH   OQI  
Date Received11/23/2015
Decision Date 01/21/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-