The following data is part of a premarket notification filed by Kyocera Medical Corporation with the FDA for Initia Total Hip System & Bioceram Azul(r) Head.
| Device ID | K160895 |
| 510k Number | K160895 |
| Device Name: | Initia Total Hip System & BIOCERAM AZUL(R) HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | KYOCERA Medical Corporation Uemura Nissei Bldg., 3-3-31 Miyahara Yodogawa-ku, JP 532-0003 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings KYOCERA Medical Corporation Uemura Nissei Bldg., 3-3-31 Miyahara Yodogawa-ku, JP 532-0003 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-31 |
| Decision Date | 2016-11-01 |
| Summary: | summary |