510(k) K040168

MODIFICATION TO GEO STRUCTURE by Interpore Cross Intl. — Product Code MQP

K040168 is an FDA 510(k) premarket notification submitted by Interpore Cross Intl. for the device "MODIFICATION TO GEO STRUCTURE". The FDA issued a decision of Substantially Equivalent on April 8, 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
April 8, 2004
Date Received
January 26, 2004
Clearance Type
Special
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