Cleared Traditional

Hercules Syndesmosis Implant System

K220260 · In2bones USA, LLC · Orthopedic
Mar 2022
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K220260 is an FDA 510(k) clearance for the Hercules Syndesmosis Implant System, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on March 31, 2022, 59 days after receiving the submission on January 31, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K220260 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2022
Decision Date March 31, 2022
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030