The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ultrack Total Knee System.
| Device ID | K953439 |
| 510k Number | K953439 |
| Device Name: | ULTRACK TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Judy English |
| Correspondent | Judy English WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-21 |
| Decision Date | 1996-01-30 |