510(k) K183197
K183197 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA, Inc. for the device "PYRAMESH Implant System". The FDA issued a decision of Substantially Equivalent on April 4, 2019. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Medtronic Sofamor Danek USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2019
- Date Received
- November 19, 2018
- 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