Cleared Traditional

CoLink PCR Plating System

K213698 · In2bones USA, LLC · Orthopedic
May 2022
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K213698 is an FDA 510(k) clearance for the CoLink PCR Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on May 27, 2022, 185 days after receiving the submission on November 23, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K213698 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2021
Decision Date May 27, 2022
Days to Decision 185 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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