EAUM TOTAL KNEE SYSTEM— 510(k) K110404
Substantially EquivalentCorentec Co., Ltd.
FDA 510(k) clearance K110404 for EAUM TOTAL KNEE SYSTEM, Substantially Equivalent on 2012-02-16. Applicant: Corentec Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Corentec Co., Ltd.
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code JWH
view allMore clearances from Corentec Co., Ltd.
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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 K110404
K-number listed on FDA's recall record- Z-1934-2024 — LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
- Z-1935-2024 — LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110404.
Data sourced from openFDA. This site is unofficial and independent of the FDA.