Platelet And Plasma Separator For Bone Graft Handling

Arthrex, Inc.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for .

Pre-market Notification Details

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• Device ID: BK180299
• 510k Number: BK180299
• Classification: Platelet And Plasma Separator For Bone Graft Handling
• Applicant: Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 US
• Product Code: ORG
• CFR Regulation Number: 864.9245 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-12-12
• Decision Date: 2019-03-07