Cleared Traditional

TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT

K132908 · Medtec, Inc. · Radiology
Mar 2014
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K132908 is an FDA 510(k) clearance for the TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on March 4, 2014, 168 days after receiving the submission on September 17, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K132908 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2013
Decision Date March 04, 2014
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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