The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Pe-plus Acetabular Cup.
| Device ID | K992153 |
| 510k Number | K992153 |
| Device Name: | PE-PLUS ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. 15-100 San Diego, CA 92121 -1122 |
| Contact | Hatmut Loch |
| Correspondent | Hatmut Loch PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. 15-100 San Diego, CA 92121 -1122 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-25 |
| Decision Date | 1999-09-23 |
| Summary: | summary |