The following data is part of a premarket notification filed by Omnilife Science with the FDA for Omni Anseris Hip Stem.
| Device ID | K171156 |
| 510k Number | K171156 |
| Device Name: | OMNI Anseris Hip Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | OMNIlife Science 480 Paramount Drive Raynham, MA 02767 |
| Contact | Christina Rovaldi |
| Correspondent | Christina Rovaldi OMNIlife Science 480 Paramount Drive Raynham, MA 02767 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-20 |
| Decision Date | 2017-08-17 |
| Summary: | summary |