510(k) K121176
K121176 is an FDA 510(k) premarket notification submitted by Cardinal Spine, LLC for the device "STGC". The FDA issued a decision of Substantially Equivalent on August 17, 2012. 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
- August 17, 2012
- Date Received
- April 18, 2012
- 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