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510(k) K193513

SIGNAFUSE Bioactive Bone Graft by Bioventus — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2020
Date Received
December 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

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