Cleared Traditional

INTEGRA PROXIMAL HUMERAL PLATE SYSTEM

K121826 · Ascension Orthopedics, Inc. · Orthopedic
Feb 2013
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K121826 is an FDA 510(k) clearance for the INTEGRA PROXIMAL HUMERAL PLATE SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on February 13, 2013, 237 days after receiving the submission on June 21, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K121826 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2012
Decision Date February 13, 2013
Days to Decision 237 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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