Cleared Special

OsteoCentric Technologies Cannulated Fasteners and Nuts

K242691 · OsteoCentric Technologies · Orthopedic
Oct 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K242691 is an FDA 510(k) clearance for the OsteoCentric Technologies Cannulated Fasteners and Nuts, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on October 9, 2024, 30 days after receiving the submission on September 9, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K242691 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2024
Decision Date October 09, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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