510(k) K130533 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
| Applicant | Tornier S.A.S., Montbonnot-Saint-Martin, FR |
| Decision | Substantially Equivalent, May 17, 2013 |
| Received | Mar 1, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130533
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Tibial Total Ankle Prosthesis
Tray, Size 2, Product No. LJU222T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T Terminated |
HSN | None listed |
| Mar 8, 2019 | Integra LifeSciences Corp. Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T Terminated |
HSN | None listed |
| Aug 26, 2015 | Tornier, Inc Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile.
Orthopedic Manual Surgical Instrument Terminated |
HSN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.