Cleared Traditional

PIONEER STERNAL CABLE PLATE SYSTEM

K122293 · Pioneer Surgical Technology, Inc. · Orthopedic
Oct 2012
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K122293 is an FDA 510(k) clearance for the PIONEER STERNAL CABLE PLATE 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 October 12, 2012, 73 days after receiving the submission on July 31, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K122293 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2012
Decision Date October 12, 2012
Days to Decision 73 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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