Cleared Traditional

K-CAP-I ORTHOPEDIC FIXATION WIRE CAP

K902053 · Westcon Orthopedics, Inc. · Orthopedic
Sep 1990
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K902053 is an FDA 510(k) clearance for the K-CAP-I ORTHOPEDIC FIXATION WIRE CAP, a Fixation Accessory (Class II — Special Controls, product code LYT), submitted by Westcon Orthopedics, Inc. (Three Bridges, US). The FDA issued a Cleared decision on September 14, 1990, 130 days after receiving the submission on May 7, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K902053 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1990
Decision Date September 14, 1990
Days to Decision 130 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code LYT — Fixation Accessory
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030