The following data is part of a premarket notification filed by Consensus Orthopedics, Inc with the FDA for Consensus Cs2 Plus Acetabular Insert.
| Device ID | K100933 |
| 510k Number | K100933 |
| Device Name: | CONSENSUS CS2 PLUS ACETABULAR INSERT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Consensus Orthopedics, Inc 1115 WINFIELD WAY SUITE 100 Eldorado Hills, CA 95762 -9623 |
| Contact | Luke Rose |
| Correspondent | Luke Rose Consensus Orthopedics, Inc 1115 WINFIELD WAY SUITE 100 Eldorado Hills, CA 95762 -9623 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-05 |
| Decision Date | 2010-10-06 |
| Summary: | summary |