Cleared Traditional

BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM

K093943 · Smith & Nephew Inc., Endoscopy Div. · Orthopedic
Mar 2010
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K093943 is an FDA 510(k) clearance for the BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM, 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 5, 2010, 73 days after receiving the submission on December 22, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K093943 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2009
Decision Date March 05, 2010
Days to Decision 73 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