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The Tracker / October 2026 / K263269

510(k) cleared

Park's Pectus System

Tdm Co., Ltd. · Oct 15, 2026 · K263269

FDA cleared the Park's Pectus System from Tdm Co., Ltd. on Oct 15, 2026 under K263269, a special 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 18, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Tdm Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K261611 (TDM Large Bone Plate and Screw System), K263062 (NOVIX Pedicle Screw System).

Questions & Answers

What did FDA clear under K263269?

K263269 is the FDA 510(k) for Park's Pectus System, submitted by Tdm Co., Ltd.. FDA's decision date was Oct 15, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Park's Pectus System?

Tdm Co., Ltd., based in Gwangju, is the applicant of record for K263269.

How long did the K263269 review take?

FDA received the submission on Sep 18, 2026 and issued its decision on Oct 15, 2026, 27 days later.

← All decisions in October 2026

Sources