Cleared Special

PIONEER SPINAL PROCESS FUSION PLATE

K110367 · Pioneer Surgical Technology, Inc. · Orthopedic
Mar 2011
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K110367 is an FDA 510(k) clearance for the PIONEER SPINAL PROCESS FUSION PLATE, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on March 23, 2011, 43 days after receiving the submission on February 8, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K110367 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2011
Decision Date March 23, 2011
Days to Decision 43 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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