Cleared Special

SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM

K141397 · Precision Spine, Inc. · Orthopedic
Jun 2014
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K141397 is an FDA 510(k) clearance for the SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on June 26, 2014, 29 days after receiving the submission on May 28, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K141397 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2014
Decision Date June 26, 2014
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNI — Orthosis, Spinal Pedicle Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070

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