510(k) K122622
K122622 is an FDA 510(k) premarket notification submitted by Lucero Medical, LLC for the device "ENDURAMESH". The FDA issued a decision of Substantially Equivalent on September 19, 2012. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Lucero Medical, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2012
- Date Received
- August 28, 2012
- 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