The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Metha Short Stem Hip System Xl Femoral Head.
| Device ID | K082146 |
| 510k Number | K082146 |
| Device Name: | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Contact | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Product Code | LWJ |
| Subsequent Product Code | KWY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-30 |
| Decision Date | 2008-09-09 |
| Summary: | summary |