510(k) K262574
K262574 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "Convoy Expandable Corpectomy System". The FDA issued a decision of Substantially Equivalent on Oct 29, 2026. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. SeaSpine Orthopedics Corporation has 68 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 29, 2026
- Date Received
- Jul 27, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Spinal Vertebral Body Replacement Device
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
- 510(k)