Cleared Traditional

MITEK TOGGLE ANCHOR(TM)

K950070 · Mitek Surgical Products, Inc. · Orthopedic
May 1995
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K950070 is an FDA 510(k) clearance for the MITEK TOGGLE ANCHOR(TM), a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Mitek Surgical Products, Inc. (Westwood, US). The FDA issued a Cleared decision on May 22, 1995, 133 days after receiving the submission on January 9, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K950070 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 1995
Decision Date May 22, 1995
Days to Decision 133 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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