510(k) K092336
K092336 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "C-THRU SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 15, 2009. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Ebi, L.P. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2009
- Date Received
- August 4, 2009
- 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