Home / 510(k) Clearances / K241564

510(k) K241564

Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS by Baxter Healthcare Corporation — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2024
Date Received
May 31, 2024
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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