510(k) K080349
K080349 is an FDA 510(k) premarket notification submitted by Signus Medizintechnik GmbH for the device "KIMBA MINI". The FDA issued a decision of Substantially Equivalent on March 10, 2008. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Signus Medizintechnik GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2008
- Date Received
- February 11, 2008
- Clearance Type
- Special
- 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