510(k) K171686
K171686 is an FDA 510(k) premarket notification submitted by Choicespine for the device "Choice Spine Hawkeye Vertebral Body Replacement (VBR) System". The FDA issued a decision of Substantially Equivalent on September 15, 2017. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Choicespine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 2017
- Date Received
- June 7, 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