The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Bi-articular Ii Hip Device.
| Device ID | K872019 |
| 510k Number | K872019 |
| Device Name: | BI-ARTICULAR II HIP DEVICE |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Max Sherman |
| Correspondent | Max Sherman ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-26 |
| Decision Date | 1987-07-21 |