The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Attune All-polyethylene Tibia.
| Device ID | K193057 |
| 510k Number | K193057 |
| Device Name: | ATTUNE All-Polyethylene Tibia |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DePuy Ireland UC Loughbeg Ringaskiddy, IE |
| Contact | Kathy Harris Brocato |
| Correspondent | Kellie Myers DePuy Synthes, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-01 |
| Decision Date | 2020-01-30 |
| Summary: | summary |