The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Mpf Acetabular Cup.
| Device ID | K011836 |
| 510k Number | K011836 |
| Device Name: | MPF ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | PLUS ORTHOPEDICS 6055 LUSK BLVD. San Diego, CA 92121 -2700 |
| Contact | Hartmut Loch |
| Correspondent | Hartmut Loch PLUS ORTHOPEDICS 6055 LUSK BLVD. San Diego, CA 92121 -2700 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-12 |
| Decision Date | 2001-09-07 |
| Summary: | summary |