The following data is part of a premarket notification filed by Consensus Orthopedics, Inc. with the FDA for Consensus Biolox Delta Ceramic Femoral Head.
| Device ID | K110542 |
| 510k Number | K110542 |
| Device Name: | CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY, SUITE 100 El Dorado Hills, CA 95762 -9623 |
| Contact | Matthew Hull |
| Correspondent | Matthew Hull CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY, SUITE 100 El Dorado Hills, CA 95762 -9623 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-24 |
| Decision Date | 2011-04-01 |
| Summary: | summary |