Synchfix EVT
FDA 510(k) clearance K251643 · decided 2025-10-29
Clearance details
- K-number
- K251643
- Device name
- Synchfix EVT
- Applicant
- Wright Medical Technology, Inc. (Stryker Corporation)
- Decision
- Substantially Equivalent
- Date received
- 2025-05-29
- Decision date
- 2025-10-29
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- HTN
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.