The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for United 36mm Ceramic Femoral Head, Delta.
| Device ID | K112463 |
| 510k Number | K112463 |
| Device Name: | UNITED 36MM CERAMIC FEMORAL HEAD, DELTA |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300 |
| Contact | Fang-yuan Ho |
| Correspondent | Fang-yuan Ho UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300 |
| Product Code | LZO |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-26 |
| Decision Date | 2011-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872179115 | K112463 | 000 |
| 04719872166849 | K112463 | 000 |
| 04712771495300 | K112463 | 000 |
| 04712771495294 | K112463 | 000 |
| 04712771495287 | K112463 | 000 |
| 04712771495270 | K112463 | 000 |
| 04719872159889 | K112463 | 000 |
| 04719872159865 | K112463 | 000 |
| 04711605586795 | K112463 | 000 |
| 04711605586788 | K112463 | 000 |
| 04711605586764 | K112463 | 000 |
| 04711605586757 | K112463 | 000 |
| 04711605586726 | K112463 | 000 |
| 04711605586719 | K112463 | 000 |
| 04711605586689 | K112463 | 000 |
| 04719872166887 | K112463 | 000 |
| 04719872166917 | K112463 | 000 |
| 04719872171058 | K112463 | 000 |
| 04719872171041 | K112463 | 000 |
| 04719872171034 | K112463 | 000 |
| 04719872171027 | K112463 | 000 |
| 04719872171010 | K112463 | 000 |
| 04719872171003 | K112463 | 000 |
| 04719872170990 | K112463 | 000 |
| 04719872170983 | K112463 | 000 |
| 04719872167075 | K112463 | 000 |
| 04719872167044 | K112463 | 000 |
| 04719872167013 | K112463 | 000 |
| 04719872166979 | K112463 | 000 |
| 04719872166948 | K112463 | 000 |
| 04719872166924 | K112463 | 000 |
| 04711605586672 | K112463 | 000 |