510(k) K192214
K192214 is an FDA 510(k) premarket notification submitted by CarboFix Orthopedics , Ltd. for the device "CarboClear VBR System". The FDA issued a decision of Substantially Equivalent on October 11, 2019. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. CarboFix Orthopedics , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2019
- Date Received
- August 15, 2019
- 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