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510(k) K080349

KIMBA MINI by Signus Medizintechnik GmbH — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2008
Date Received
February 11, 2008
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

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