Stryker SonicPin System— 510(k) K170418
Substantially EquivalentStryker Trauma GmbH
FDA 510(k) clearance K170418 for Stryker SonicPin System, Substantially Equivalent on 2017-06-20. Applicant: Stryker Trauma GmbH. Device class: 2.
Clearance details
- Applicant
- Stryker Trauma GmbH
- Product code
- Code HTY
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schoenkirchen, DE
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Adverse events under product code HTY
product code HTY- Injury
- 544
- Total
- 544
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.