Cleared Traditional

SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR

K093897 · Smith & Nephew Inc., Endoscopy Div. · Orthopedic
Mar 2010
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K093897 is an FDA 510(k) clearance for the SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Smith & Nephew Inc., Endoscopy Div. (Andover, US). The FDA issued a Cleared decision on March 4, 2010, 76 days after receiving the submission on December 18, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K093897 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2009
Decision Date March 04, 2010
Days to Decision 76 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040