510(k) K040928
K040928 is an FDA 510(k) premarket notification submitted by Interpore Cross Intl. for the device "EXPANDABLE PEEK VBR IMPLANT". The FDA issued a decision of Substantially Equivalent on August 27, 2004. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Interpore Cross Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2004
- Date Received
- April 9, 2004
- 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