K251643
- 510(k) number
- K251643
- Device name
- Synchfix EVT
- Applicant
- Wright Medical Technology, Inc. (Stryker Corporation) TN · US
- Product code
- HTN — Washer, Bolt Nut
- Decision date
- 2025-10-29
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251643.pdf
Official FDA record: K251643
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.