ULTRAFUSE

Filler, Bone Void, Calcium Compound

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Ultrafuse.

Pre-market Notification Details

• Device ID: K130531
• 510k Number: K130531
• Device Name: ULTRAFUSE
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: BAXTER HEALTHCARE CORP. ONE BAXTER WAY Westlake Village, CA 91362
• Contact: Gretchen Murray
• Correspondent: Gretchen Murray; BAXTER HEALTHCARE CORP. ONE BAXTER WAY Westlake Village, CA 91362
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-01
• Decision Date: 2014-04-08
• Summary: summary