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510(k) K080108

CORTOSS BONE AUGMENTATION MATERIAL by Orthovita, Inc. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2009
Date Received
January 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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