Cleared Traditional

ANCHORMAN Tibial Ligament Fixation Device

K170388 · Summit Medical , Ltd. · Orthopedic
Jul 2017
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K170388 is an FDA 510(k) clearance for the ANCHORMAN Tibial Ligament Fixation Device, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Summit Medical , Ltd. (Bourton On The Water, GB). The FDA issued a Cleared decision on July 25, 2017, 167 days after receiving the submission on February 8, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K170388 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2017
Decision Date July 25, 2017
Days to Decision 167 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