Cleared Traditional

UNITY BETA PLLA SYSTEM

K090175 · Bonutti Research, Inc. · Orthopedic
Sep 2009
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K090175 is an FDA 510(k) clearance for the UNITY BETA PLLA 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 September 10, 2009, 230 days after receiving the submission on January 23, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K090175 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2009
Decision Date September 10, 2009
Days to Decision 230 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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