Cleared Traditional

Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS

K241564 · Baxter Healthcare Corporation · Orthopedic
Aug 2024
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K241564 is an FDA 510(k) clearance for the Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on August 2, 2024, 63 days after receiving the submission on May 31, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K241564 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2024
Decision Date August 02, 2024
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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