Cleared Traditional

SBI DISTAL RADIUS VOLAR PLATING SYSTEM

K070793 · Small Bone Innovations, Inc. · Orthopedic
May 2007
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K070793 is an FDA 510(k) clearance for the SBI DISTAL RADIUS VOLAR PLATING SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Small Bone Innovations, Inc. (New York, US). The FDA issued a Cleared decision on May 30, 2007, 69 days after receiving the submission on March 22, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K070793 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2007
Decision Date May 30, 2007
Days to Decision 69 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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