The following data is part of a premarket notification filed by Otis Biotech Co., Ltd with the FDA for Multifit Total Hip System.
| Device ID | K101472 |
| 510k Number | K101472 |
| Device Name: | MULTIFIT TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | OTIS BIOTECH CO., LTD 514, 2-BA BLOCK JEONGWANG-DONG Siheung-si, Gyounggi-do, KR 429-450 |
| Contact | Srinivasareddy Krotha |
| Correspondent | Srinivasareddy Krotha OTIS BIOTECH CO., LTD 514, 2-BA BLOCK JEONGWANG-DONG Siheung-si, Gyounggi-do, KR 429-450 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-27 |
| Decision Date | 2011-01-05 |
| Summary: | summary |