510(k) K183054
K183054 is an FDA 510(k) premarket notification submitted by Depuy Synthes Spine for the device "SYNMESH System". The FDA issued a decision of Substantially Equivalent on May 23, 2019. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Depuy Synthes Spine has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2019
- Date Received
- November 2, 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