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510(k) K233490

SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty by Bioventus, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2023
Date Received
October 27, 2023
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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