The following data is part of a premarket notification filed by Aesculap Implant Systems with the FDA for Enduro Knee System.
| Device ID | K101815 |
| 510k Number | K101815 |
| Device Name: | ENDURO KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Contact | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-30 |
| Decision Date | 2010-12-20 |
| Summary: | summary |