Cleared Traditional

BONE ANCHOR FOR SOFT TISSUE ATTACHMENT

K932925 · Vesitec Medical, Inc. · Orthopedic

Apr 1994

Decision

315d

Days

Class 2

Risk

About This 510(k) Submission

K932925 is an FDA 510(k) clearance for the BONE ANCHOR FOR SOFT TISSUE ATTACHMENT, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Vesitec Medical, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on April 26, 1994, 315 days after receiving the submission on June 15, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K932925 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 1993
Decision Date	April 26, 1994
Days to Decision	315 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF