510(k) K261031
K261031 is an FDA 510(k) premarket notification submitted by Signus Medinzintechnik GmbH for the device "POSEIDON ST". The FDA issued a decision of Substantially Equivalent on July 10, 2026. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2026
- Date Received
- March 30, 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