Cleared Traditional

SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061

K092754 · Small Bone Innovations, Inc. · Orthopedic
Jan 2010
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K092754 is an FDA 510(k) clearance for the SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Small Bone Innovations, Inc. (Morrisville, US). The FDA issued a Cleared decision on January 19, 2010, 132 days after receiving the submission on September 9, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K092754 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2009
Decision Date January 19, 2010
Days to Decision 132 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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