510(k) K051659

SEMIAL SPINAL IMPLANT by Signus Medizintechnik GmbH — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2005
Date Received
June 22, 2005
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