T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP— 510(k) K112059
Substantially EquivalentStryker
FDA 510(k) clearance K112059 for T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP, Substantially Equivalent on 2011-08-08. Applicant: Stryker. Device class: 2.
Clearance details
- Applicant
- Stryker
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mahwah, NJ, US
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- K253046 — HERA Interlocking Intramedullary Nailing System
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Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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.