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 |