Cleared Traditional

K-CAP-I, STERILE

K912762 · Westcon Orthopedics, Inc. · Orthopedic

Jul 1991

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K912762 is an FDA 510(k) clearance for the K-CAP-I, STERILE, 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 July 18, 1991, 24 days after receiving the submission on June 24, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K912762 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 1991
Decision Date	July 18, 1991
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement