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 Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/23/2015 |
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
|
Recalls |
CDRH Recalls
|
|
|