The following data is part of a premarket notification filed by Consensus Orthopedics, Inc. with the FDA for Unisyn Plus Hip Stem.
| Device ID | K120595 |
| 510k Number | K120595 |
| Device Name: | UNISYN PLUS HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY STE 100 El Dorado Hills, CA 95762 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull CONSENSUS ORTHOPEDICS, INC. 1115 WINDFIELD WAY STE 100 El Dorado Hills, CA 95762 |
| Product Code | LWJ |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-28 |
| Decision Date | 2012-10-12 |
| Summary: | summary |