The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Bi-loc Bipolar Cup.
| Device ID | K961793 |
| 510k Number | K961793 |
| Device Name: | BI-LOC BIPOLAR CUP |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Contact | Michelle M Perry |
| Correspondent | Michelle M Perry ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-09 |
| Decision Date | 1996-07-26 |