Cleared Special

1ST MTP PLATE

K133437 · Osteomed · Orthopedic
Dec 2013
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K133437 is an FDA 510(k) clearance for the 1ST MTP PLATE, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on December 2, 2013, 25 days after receiving the submission on November 7, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K133437 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2013
Decision Date December 02, 2013
Days to Decision 25 days
Submission Type Special
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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