The following data is part of a premarket notification filed by Consensus Orthopedics, Inc. with the FDA for Taper Set Hip System Rdp Stem.
| Device ID | K121263 |
| 510k Number | K121263 |
| Device Name: | TAPER SET HIP SYSTEM RDP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY STE 100 El Dorado Hills, CA 95762 |
| Product Code | LPH |
| Subsequent Product Code | KWL |
| 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 | 2012-04-26 |
| Decision Date | 2012-05-22 |
| Summary: | summary |