510(k) K142030
K142030 is an FDA 510(k) premarket notification submitted by Cardinal Spine, LLC for the device "STGC-LORDOTIC". The FDA issued a decision of Substantially Equivalent on January 23, 2015. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Cardinal Spine, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2015
- Date Received
- July 25, 2014
- 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