Actifuse Flow

Filler, Bone Void, Calcium Compound

Baxter Healthcare Corporation

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Actifuse Flow.

Pre-market Notification Details

Device IDK181306
510k NumberK181306
Device Name:Actifuse Flow
ClassificationFiller, Bone Void, Calcium Compound
Applicant Baxter Healthcare Corporation 32650 N Wilson Rd Round Lake,  IL  60073
ContactDaniel Davis
CorrespondentDaniel Davis
Baxter Healthcare Corporation 32650 N Wilson Rd Round Lake,  IL  60073
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-17
Decision Date2018-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
55060050780789 K181306 000
55060050780772 K181306 000
55060050780765 K181306 000

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