510(k) K250251
K250251 is an FDA 510(k) premarket notification submitted by Dev4 for the device "Eleganz Fusion Screw System (Fusion Screw System)". The FDA issued a decision of Substantially Equivalent on June 13, 2025. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Dev4 has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2025
- Date Received
- January 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type