Cleared Traditional

KLS Martin Orthopedic Implants - MR Conditional

K241018 · KLS-Martin L.P. · Orthopedic
Jul 2024
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K241018 is an FDA 510(k) clearance for the KLS Martin Orthopedic Implants - MR Conditional, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on July 12, 2024, 88 days after receiving the submission on April 15, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K241018 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2024
Decision Date July 12, 2024
Days to Decision 88 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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