The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Attune Revision Lps Inserts.
| Device ID | K191779 |
| 510k Number | K191779 |
| Device Name: | Attune Revision LPS Inserts |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | Depuy (Ireland) Loughbeg Ringaskiddy Co. Cork Munster, IE |
| Contact | Kathy Harris |
| Correspondent | Soraya L. Hori Depuy Orthopaedies, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-02 |
| Decision Date | 2019-10-08 |
| Summary: | summary |