Cleared Traditional

UNITY ALPHA SYSTEM

K062820 · Bonutti Research, Inc. · Orthopedic
Mar 2007
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K062820 is an FDA 510(k) clearance for the UNITY ALPHA SYSTEM, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Bonutti Research, Inc. (Effingham, US). The FDA issued a Cleared decision on March 15, 2007, 176 days after receiving the submission on September 20, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K062820 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2006
Decision Date March 15, 2007
Days to Decision 176 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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