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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K241564
Device Name Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS
Applicant
Baxter Healthcare Corporation
25212 W. Illinois
Route 120
Round Lake,  IL  60073
Applicant Contact Phillip Romei
Correspondent
Baxter Healthcare Corporation
25212 W. Illinois
Route 120
Round Lake,  IL  60073
Correspondent Contact Phillip Romei
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/31/2024
Decision Date 08/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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