The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Excia Total Hip System.
| Device ID | K042344 |
| 510k Number | K042344 |
| Device Name: | EXCIA TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Joyce Kilroy |
| Correspondent | Joyce Kilroy AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | LWJ |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-30 |
| Decision Date | 2005-03-16 |
| Summary: | summary |