Cleared Special

OsteoCentric Integrated Hip Fastener System

K230764 · OsteoCentric Technologies · Orthopedic
Apr 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K230764 is an FDA 510(k) clearance for the OsteoCentric Integrated Hip Fastener System, a Device, Fixation, Proximal Femoral, Implant (Class II — Special Controls, product code JDO), submitted by OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on April 18, 2023, 29 days after receiving the submission on March 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K230764 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2023
Decision Date April 18, 2023
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDO — Device, Fixation, Proximal Femoral, Implant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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