Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K160895 |
Device Name |
Initia Total Hip System & BIOCERAM AZUL(R) HEAD |
Applicant |
KYOCERA Medical Corporation |
Uemura Nissei Bldg., 3-3-31 Miyahara |
Yodogawa-ku,
JP
532-0003
|
|
Applicant Contact |
Cheryl Hastings |
Correspondent |
KYOCERA Medical Corporation |
Uemura Nissei Bldg., 3-3-31 Miyahara |
Yodogawa-ku,
JP
532-0003
|
|
Correspondent Contact |
Cheryl Hastings |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/31/2016 |
Decision Date | 11/01/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|