Cleared Traditional

K993657 - ACUMED SUTURE ANCHOR
(FDA 510(k) Clearance)

K993657 · Acu Med, Inc. · Orthopedic
Jan 2000
Decision
77d
Days
Class 2
Risk

K993657 is an FDA 510(k) clearance for the ACUMED SUTURE ANCHOR, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on January 13, 2000, 77 days after receiving the submission on October 28, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K993657 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1999
Decision Date January 13, 2000
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040