510(k) K182878 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Integra Salto Total Ankle System
| Applicant | Ascension Orthopedics, Austin TX, US |
| Decision | Substantially Equivalent, Dec 18, 2018 |
| Received | Oct 15, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182878
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T Terminated |
HSN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.