Integra Salto Total Ankle System— 510(k) K182878
Substantially EquivalentAscension Orthopedics
FDA 510(k) clearance K182878 for Integra Salto Total Ankle System, Substantially Equivalent on 2018-12-18. Applicant: Ascension Orthopedics. Device class: 2.
Clearance details
- Applicant
- Ascension Orthopedics
- 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
- Austin, TX, US
Recent devices under product code HSN
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view all- K162153 — Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System
- K160830 — Integra External Fixation System
- K152047 — INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
- K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System
- K151459 — Integra Total Ankle Replacement System
Adverse 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 K182878
K-number listed on FDA's recall record- Z-1168-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
- Z-1169-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
- Z-1170-2019 — Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
- Z-1171-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
- Z-1172-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
- Z-1173-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
- Z-1174-2019 — Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
- Z-1175-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182878.
Data sourced from openFDA. This site is unofficial and independent of the FDA.