The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Metha Hip System.
| Device ID | K071916 |
| 510k Number | K071916 |
| Device Name: | METHA HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. Center Valley, PA 18034 |
| Contact | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. Center Valley, PA 18034 |
| Product Code | MEH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-11 |
| Decision Date | 2008-06-02 |
| Summary: | summary |