TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL

Fastener, Fixation, Nondegradable, Soft Tissue

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Twinfix Ti 3.5mm Suture Anchor With Two Ultrabraid Suture #2 With Needles, Sl.

Pre-market Notification Details

• Device ID: K123425
• 510k Number: K123425
• Device Name: TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
• Classification: Fastener, Fixation, Nondegradable, Soft Tissue
• Applicant: SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810
• Contact: Catherine Kilshaw
• Correspondent: Catherine Kilshaw; SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810
• Product Code: MBI
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-07
• Decision Date: 2013-02-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885554029291	K123425	000
00885554029284	K123425	000
00885554029277	K123425	000