The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Epf-plus Cementless Press-fit Acetabular Cup.
| Device ID | K994146 |
| 510k Number | K994146 |
| Device Name: | EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | PLUS ORTHOPEDICS 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94553 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf PLUS ORTHOPEDICS 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94553 -3389 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-08 |
| Decision Date | 2000-12-11 |
| Summary: | summary |