The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Plus Orthopedics Cemented Hip Stem.
| Device ID | K031165 |
| 510k Number | K031165 |
| Device Name: | PLUS ORTHOPEDICS CEMENTED HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | PLUS ORTHOPEDICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 -2700 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb PLUS ORTHOPEDICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 -2700 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2003-06-06 |
| Summary: | summary |