Cleared Traditional

Pectus Blu Support Bar System

K241709 · Biomet Microfixation · Orthopedic
Sep 2024
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K241709 is an FDA 510(k) clearance for the Pectus Blu Support Bar System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on September 19, 2024, 98 days after receiving the submission on June 13, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K241709 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2024
Decision Date September 19, 2024
Days to Decision 98 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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