Cleared Traditional

K-CAPE ORTHOPEDIC WIRES AND PINS

K901525 · Westcon Orthopedics, Inc. · Orthopedic

Apr 1990

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K901525 is an FDA 510(k) clearance for the K-CAPE ORTHOPEDIC WIRES AND PINS, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Westcon Orthopedics, Inc. (Three Bridges, US). The FDA issued a Cleared decision on April 23, 1990, 21 days after receiving the submission on April 2, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K901525 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 1990
Decision Date	April 23, 1990
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030