The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for U-motion Ii Acetabular System— Additional Sizes.
| Device ID | K170089 |
| 510k Number | K170089 |
| Device Name: | U-Motion II Acetabular System— Additional Sizes |
| 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 | Gimpel Chien |
| Correspondent | Gimpel Chien United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu, TW 300 |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-10 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872162049 | K170089 | 000 |
| 04711605580694 | K170089 | 000 |
| 04711605580687 | K170089 | 000 |
| 04711605580670 | K170089 | 000 |
| 04711605580663 | K170089 | 000 |
| 04711605580656 | K170089 | 000 |
| 04711605580649 | K170089 | 000 |
| 04711605580571 | K170089 | 000 |
| 04711605580564 | K170089 | 000 |
| 04711605580557 | K170089 | 000 |
| 04711605580540 | K170089 | 000 |
| 04711605580533 | K170089 | 000 |
| 04711605580700 | K170089 | 000 |
| 04711605580717 | K170089 | 000 |
| 04719872161912 | K170089 | 000 |
| 04719872161707 | K170089 | 000 |
| 04719872161677 | K170089 | 000 |
| 04711605580816 | K170089 | 000 |
| 04711605580809 | K170089 | 000 |
| 04711605580793 | K170089 | 000 |
| 04711605580786 | K170089 | 000 |
| 04711605580779 | K170089 | 000 |
| 04711605580748 | K170089 | 000 |
| 04711605580731 | K170089 | 000 |
| 04711605580724 | K170089 | 000 |
| 04711605580526 | K170089 | 000 |