Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K152903 |
Device Name |
REVIVAL(TM) Modular Revision Hip Stem |
Applicant |
CORIN USA |
5670 W CYPRESS STREET |
TAMPA,
FL
33607
|
|
Applicant Contact |
DIANA L. NADER-MARTONE |
Correspondent |
CORIN USA |
5670 W CYPRESS STREET |
TAMPA,
FL
33607
|
|
Correspondent Contact |
DIANA L. NADER-MARTONE |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/01/2015 |
Decision Date | 04/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|