The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Excia Total Hip System Lateral Offset.
| Device ID | K061344 |
| 510k Number | K061344 |
| Device Name: | EXCIA TOTAL HIP SYSTEM LATERAL OFFSET |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | JDI |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-15 |
| Decision Date | 2006-08-02 |
| Summary: | summary |