Cleared Traditional

PIONEER STERNAL ASSIST IMPLANT SYSTEM

K120016 · Pioneer Surgical Technology, Inc. · Orthopedic
Jul 2012
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K120016 is an FDA 510(k) clearance for the PIONEER STERNAL ASSIST IMPLANT SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on July 26, 2012, 205 days after receiving the submission on January 3, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K120016 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2012
Decision Date July 26, 2012
Days to Decision 205 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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