The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Advance Total Knee System.
| Device ID | K061223 |
| 510k Number | K061223 |
| Device Name: | ADVANCE TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Theresa Leister |
| Correspondent | Theresa Leister WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-02 |
| Decision Date | 2006-08-18 |
| Summary: | summary |