MultiFIX® P Knotless Fixation Device

Fastener, Fixation, Nondegradable, Soft Tissue

ArthroCare Corporation

The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Multifix® P Knotless Fixation Device.

Pre-market Notification Details

• Device ID: K151897
• 510k Number: K151897
• Device Name: MultiFIX® P Knotless Fixation Device
• Classification: Fastener, Fixation, Nondegradable, Soft Tissue
• Applicant: ArthroCare Corporation 15285 Alton Parkway, Suite 200 Irvine, CA 92618
• Contact: Laura Kasperowicz
• Correspondent: Laura Kasperowicz; ArthroCare Corporation 15285 Alton Parkway, Suite 200 Irvine, CA 92618
• Product Code: MBI
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-10
• Decision Date: 2015-08-06
• Summary: summary