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 |