Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®— 510(k) K230416
Substantially EquivalentStryker
FDA 510(k) clearance K230416 for Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®, Substantially Equivalent on 2023-05-19. Applicant: Stryker. Device class: 2.
Clearance details
- Applicant
- Stryker
- Product code
- Code KRO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3510
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
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Adverse events under product code KRO
product code KRO- Death
- 19
- Injury
- 4,841
- Total
- 4,860
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.