The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Advance Ultra-congruent Tibial Insert.
| Device ID | K972770 |
| 510k Number | K972770 |
| Device Name: | ADVANCE ULTRA-CONGRUENT TIBIAL INSERT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Dan Regan |
| Correspondent | Dan Regan 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 | 1997-07-24 |
| Decision Date | 1997-10-21 |
| Summary: | summary |