Cleared Traditional

WELLS JOHNSON FIXATION SYSTEM

K945500 · Wells Johnson Co. · Orthopedic
Sep 1995
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K945500 is an FDA 510(k) clearance for the WELLS JOHNSON FIXATION SYSTEM, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on September 21, 1995, 316 days after receiving the submission on November 9, 1994. This device falls under the Orthopedic review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K945500 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1994
Decision Date September 21, 1995
Days to Decision 316 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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