The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Columbus Total Knee System Mios Cr/ps Tibial Tray.
| Device ID | K071499 |
| 510k Number | K071499 |
| Device Name: | COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-31 |
| Decision Date | 2007-09-14 |
| Summary: | summary |