Cleared Traditional

HS Fiber Cerclage

K220765 · Riverpoint Medical, LLC · Orthopedic
Jul 2023
Decision
497d
Days
Class 2
Risk

About This 510(k) Submission

K220765 is an FDA 510(k) clearance for the HS Fiber Cerclage, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Riverpoint Medical, LLC (Portland, US). The FDA issued a Cleared decision on July 26, 2023, 497 days after receiving the submission on March 16, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K220765 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2022
Decision Date July 26, 2023
Days to Decision 497 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDQ — Cerclage, Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3010

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