Cleared Traditional

AFFINITY Proximal Tibia System

K220199 · Techfit Digital Surgery, Inc. · Orthopedic
Mar 2022
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K220199 is an FDA 510(k) clearance for the AFFINITY Proximal Tibia System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Techfit Digital Surgery, Inc. (Daytona Beach, US). The FDA issued a Cleared decision on March 21, 2022, 56 days after receiving the submission on January 24, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K220199 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2022
Decision Date March 21, 2022
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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