The following data is part of a premarket notification filed by Omnilife Science with the FDA for Omni Arc Monoblock Hip Stem.
| Device ID | K133381 |
| 510k Number | K133381 |
| Device Name: | OMNI ARC MONOBLOCK HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | OMNILIFE SCIENCE 10 O'CONNELL WAY, STE 10 East Taunton, MA 02718 |
| Contact | Christina Flores |
| Correspondent | Christina Flores OMNILIFE SCIENCE 10 O'CONNELL WAY, STE 10 East Taunton, MA 02718 |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-04 |
| Decision Date | 2014-03-13 |
| Summary: | summary |