510(k) K251643
K251643 is an FDA 510(k) premarket notification submitted by Wright Medical Technology, Inc. (Stryker Corporation) for the device "Synchfix EVT". The FDA issued a decision of Substantially Equivalent on October 29, 2025. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Wright Medical Technology, Inc. (Stryker Corporation) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2025
- Date Received
- May 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Bolt Nut
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type