510(k) K173800
K173800 is an FDA 510(k) premarket notification submitted by Camber Spine Technologies for the device "Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage". The FDA issued a decision of Substantially Equivalent on February 2, 2018. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Camber Spine Technologies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2018
- Date Received
- December 14, 2017
- 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