The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Plus-fit Acetabular Cup.
| Device ID | K973077 |
| 510k Number | K973077 |
| Device Name: | PLUS-FIT ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | PLUS ORTHOPEDICS 835 CORTEZ LN. Forest City, CA 94404 |
| Contact | Hartmut Loch |
| Correspondent | Hartmut Loch PLUS ORTHOPEDICS 835 CORTEZ LN. Forest City, CA 94404 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1997-11-13 |
| Summary: | summary |