Cleared Traditional

MITEK GII ANCHOR

K953877 · Mitek Surgical Products, Inc. · Orthopedic
Dec 1995
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K953877 is an FDA 510(k) clearance for the MITEK GII ANCHOR, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Mitek Surgical Products, Inc. (Westwood, US). The FDA issued a Cleared decision on December 29, 1995, 165 days after receiving the submission on July 17, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K953877 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1995
Decision Date December 29, 1995
Days to Decision 165 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