The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Columbus Ultra Congruent (uc) Tibial Insert/gliding Surface.
| Device ID | K053579 |
| 510k Number | K053579 |
| Device Name: | COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-22 |
| Decision Date | 2006-05-17 |
| Summary: | summary |