The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Bicon-plus Acetabular Components.
| Device ID | K992154 |
| 510k Number | K992154 |
| Device Name: | BICON-PLUS ACETABULAR COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. 15-100 San Diego, CA 92121 -1122 |
| Contact | Hartmut Loch |
| Correspondent | Hartmut Loch PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. 15-100 San Diego, CA 92121 -1122 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-25 |
| Decision Date | 2000-04-06 |
| Summary: | summary |