The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Femoral Heads, 2.5 And 7.5 Mm Neck Length.
| Device ID | K122504 |
| 510k Number | K122504 |
| Device Name: | FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-16 |
| Decision Date | 2012-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872171171 | K122504 | 000 |
| 04719872159414 | K122504 | 000 |
| 04719872159407 | K122504 | 000 |
| 04719872159391 | K122504 | 000 |
| 04712771497434 | K122504 | 000 |
| 04712771497427 | K122504 | 000 |
| 04712771497410 | K122504 | 000 |
| 04712771497403 | K122504 | 000 |
| 04712771497397 | K122504 | 000 |
| 04719872159421 | K122504 | 000 |
| 04719872159438 | K122504 | 000 |
| 04719872171140 | K122504 | 000 |
| 04719872159674 | K122504 | 000 |
| 04719872159667 | K122504 | 000 |
| 04719872159650 | K122504 | 000 |
| 04719872159643 | K122504 | 000 |
| 04719872159636 | K122504 | 000 |
| 04719872159629 | K122504 | 000 |
| 04719872159445 | K122504 | 000 |
| 04712771497380 | K122504 | 000 |