The following data is part of a premarket notification filed by Omnlife Science with the FDA for Apex Modular Head, Size 28 ,32, 26 And 40 Mm+10.5 Offset, Models 302810, 303210,303610,304010.
| Device ID | K101575 |
| 510k Number | K101575 |
| Device Name: | APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | OMNLIFE SCIENCE 50 O'CONNELL WAY East Taunton, MA 02718 |
| Contact | Radhika Pondicherry |
| Correspondent | Radhika Pondicherry OMNLIFE SCIENCE 50 O'CONNELL WAY East Taunton, MA 02718 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-07 |
| Decision Date | 2010-06-30 |
| Summary: | summary |