The following data is part of a premarket notification filed by Omnilife Science Inc. with the FDA for Apex K1 Hip Stem.
| Device ID | K110947 |
| 510k Number | K110947 |
| Device Name: | APEX K1 HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | OMNILIFE SCIENCE INC. 50 O'CONNELL WAY East Taunton, MA 02718 |
| Contact | Radhika Pondicherry |
| Correspondent | Radhika Pondicherry OMNILIFE SCIENCE INC. 50 O'CONNELL WAY East Taunton, MA 02718 |
| Product Code | LPH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-04 |
| Decision Date | 2011-06-16 |
| Summary: | summary |