Synchfix EVT— 510(k) K251643
Substantially EquivalentWright Medical Technology, Inc. (Stryker Corporation)
FDA 510(k) clearance K251643 for Synchfix EVT, Substantially Equivalent on 2025-10-29. Applicant: Wright Medical Technology, Inc. (Stryker Corporation).
Clearance details
- Applicant
- Wright Medical Technology, Inc. (Stryker Corporation)
- Product code
- Code HTN
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Adverse events under product code HTN
product code HTN- Injury
- 310
- Malfunction
- 639
- Total
- 949
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.