FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, 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 Footprint Ultra Pk4.5mm And 5.5mm Suture Anchor, Sl.

Pre-market Notification Details

• Device ID: K123579
• 510k Number: K123579
• Device Name: FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
• Classification: Fastener, Fixation, Nondegradable, Soft Tissue
• Applicant: SMITH & NEPHEW, INC. 150 Minuteman Road Andover, MA 01810
• Contact: Catherine Kilshaw
• Correspondent: Catherine Kilshaw; SMITH & NEPHEW, INC. 150 Minuteman Road Andover, MA 01810
• Product Code: MBI
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-19
• Decision Date: 2013-01-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885554029963	K123579	000