The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Bipolar Acetabular Cup.
| Device ID | K060707 |
| 510k Number | K060707 |
| Device Name: | AESCULAP BIPOLAR ACETABULAR CUP |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-16 |
| Decision Date | 2006-05-31 |
| Summary: | summary |