Cleared Traditional

KMI DISTAL VOLAR RADIUS PLATE SYSTEM

K041461 · Kinetikos Medical, Inc. · Orthopedic
Aug 2004
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K041461 is an FDA 510(k) clearance for the KMI DISTAL VOLAR RADIUS PLATE SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Kinetikos Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 16, 2004, 75 days after receiving the submission on June 2, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K041461 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2004
Decision Date August 16, 2004
Days to Decision 75 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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