510(k) K191779 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Attune Revision LPS Inserts
| Applicant | Depuy(Ireland), Cork, IE |
| Decision | Substantially Equivalent, Oct 8, 2019 |
| Received | Jul 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191779
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2023 | DePuy Orthopaedics, Inc. Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118 Open, Classified |
KRO | None listed |
| Mar 17, 2023 | DePuy Orthopaedics, Inc. Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212 Open, Classified |
KRO | None listed |
| Mar 17, 2023 | DePuy Orthopaedics, Inc. Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226 Open, Classified |
KRO | None listed |
| Mar 17, 2023 | DePuy Orthopaedics, Inc. Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312 Open, Classified |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.