5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP

Fastener, Fixation, Nondegradable, Soft Tissue

ARTHROCARE CORP.

The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for 5.5 / 6.5mm Spartan Peek Surture Implant With #2 Magnumwire / With Needles, Extraction Tool, 5.5 / 6.5mm Punch Tap.

Pre-market Notification Details

• Device ID: K110781
• 510k Number: K110781
• Device Name: 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP
• Classification: Fastener, Fixation, Nondegradable, Soft Tissue
• Applicant: ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523
• Contact: Valerie Defiesta-ng
• Correspondent: Valerie Defiesta-ng; ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523
• Product Code: MBI
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-21
• Decision Date: 2011-05-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817470009514	K110781	000
00817470002973	K110781	000
00817470002966	K110781	000
00817470001297	K110781	000
00817470001273	K110781	000