510(k) K171704
K171704 is an FDA 510(k) premarket notification submitted by K2M for the device "CAPRI Corpectomy Cage System". The FDA issued a decision of Substantially Equivalent on Aug 31, 2017. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. K2M has 123 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 31, 2017
- Date Received
- Jun 8, 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
- 510(k)