Cleared Special

UNITY BETA ANCHOR SYSTEM

K082906 · Bonutti Research, Inc. · Orthopedic
Oct 2008
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K082906 is an FDA 510(k) clearance for the UNITY BETA ANCHOR 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 October 30, 2008, 30 days after receiving the submission on September 30, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K082906 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2008
Decision Date October 30, 2008
Days to Decision 30 days
Submission Type Special
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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