TRIGEN Stable Lock Nut & Washer— 510(k) K243608
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K243608 for TRIGEN Stable Lock Nut & Washer, Substantially Equivalent on 2025-06-12. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code JDS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
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Adverse events under product code JDS
product code JDS- Injury
- 1,776
- Malfunction
- 1,509
- Total
- 3,285
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.