SALTO TALARIS TOTAL ANKLE PROSTHESIS— 510(k) K090076
Substantially EquivalentTornier
FDA 510(k) clearance K090076 for SALTO TALARIS TOTAL ANKLE PROSTHESIS, Substantially Equivalent on 2009-03-17. Applicant: Tornier. Device class: 2.
Clearance details
- Applicant
- Tornier
- Product code
- Code HSN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3110
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Saint-Ismier Cedex, FR
Recent devices under product code HSN
view allMore clearances from Tornier
view allAdverse events under product code HSN
product code HSN- Death
- 3
- Injury
- 4,711
- Total
- 4,714
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K090076
K-number listed on FDA's recall record- Z-1150-2019 — Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T
- Z-1151-2019 — Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
- Z-1152-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
- Z-1153-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T
- Z-1154-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T
- Z-1155-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T
- Z-1156-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T
- Z-1157-2019 — Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T
- Z-1158-2019 — Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T
- Z-1159-2019 — Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T
- Z-1160-2019 — Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
- Z-1161-2019 — Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
- Z-1162-2019 — Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
- Z-1163-2019 — Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
- Z-1164-2019 — Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T
- Z-1165-2019 — Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T
- Z-1166-2019 — Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
- Z-1167-2019 — Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090076.
Data sourced from openFDA. This site is unofficial and independent of the FDA.