Cleared Traditional

OSSIOfiber? Threaded Trimmable Fixation Nail

K241277 · OSSIO , Ltd. · Orthopedic
Jul 2024
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K241277 is an FDA 510(k) clearance for the OSSIOfiber? Threaded Trimmable Fixation Nail, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on July 3, 2024, 58 days after receiving the submission on May 6, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K241277 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2024
Decision Date July 03, 2024
Days to Decision 58 days
Submission Type Traditional
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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