Cleared Traditional

SOFT TISSUE SUTURE WASHER

K991135 · Depuy, Inc. · Orthopedic
Apr 1999
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K991135 is an FDA 510(k) clearance for the SOFT TISSUE SUTURE WASHER, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 29, 1999, 24 days after receiving the submission on April 5, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K991135 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1999
Decision Date April 29, 1999
Days to Decision 24 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030