The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for U2 Acetabular Cup.
| Device ID | K022520 |
| 510k Number | K022520 |
| Device Name: | U2 ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300 |
| Contact | Jiann-jong Liau |
| Correspondent | Jiann-jong Liau UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-30 |
| Decision Date | 2003-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872177753 | K022520 | 000 |
| 04712771506679 | K022520 | 000 |
| 04712771506662 | K022520 | 000 |
| 04712602341554 | K022520 | 000 |
| 04712602341486 | K022520 | 000 |
| 04712602341431 | K022520 | 000 |
| 04712602341394 | K022520 | 000 |
| 04711605560986 | K022520 | 000 |
| 04719872159735 | K022520 | 000 |
| 04719872159728 | K022520 | 000 |
| 04719872159506 | K022520 | 000 |
| 04719872159490 | K022520 | 000 |
| 04719872159186 | K022520 | 000 |
| 04719872159315 | K022520 | 000 |
| 04719872159308 | K022520 | 000 |
| 04712771506686 | K022520 | 000 |
| 04712771506693 | K022520 | 000 |
| 04712771506709 | K022520 | 000 |
| 04712771507041 | K022520 | 000 |
| 04712771507034 | K022520 | 000 |
| 04712771507027 | K022520 | 000 |
| 04712771507010 | K022520 | 000 |
| 04712771507003 | K022520 | 000 |
| 04712771506990 | K022520 | 000 |
| 04712771506983 | K022520 | 000 |
| 04712771506976 | K022520 | 000 |
| 04712771506969 | K022520 | 000 |
| 04712771506754 | K022520 | 000 |
| 04712771506747 | K022520 | 000 |
| 04712771506730 | K022520 | 000 |
| 04712771506723 | K022520 | 000 |
| 04712771506716 | K022520 | 000 |
| 04719872159193 | K022520 | 000 |