Cleared Traditional

K980103 - ACUMED SUTURE ANCHOR
(FDA 510(k) Clearance)

K980103 · Acu Med, Inc. · Orthopedic
Mar 1998
Decision
63d
Days
Class 2
Risk

K980103 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 March 16, 1998, 63 days after receiving the submission on January 12, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K980103 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1998
Decision Date March 16, 1998
Days to Decision 63 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