Cleared Traditional

K-CAP-E, STERILE

K914812 · Westcon Orthopedics, Inc. · Orthopedic

Jan 1992

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K914812 is an FDA 510(k) clearance for the K-CAP-E, 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 January 9, 1992, 76 days after receiving the submission on October 25, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K914812 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 1991
Decision Date	January 09, 1992
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement