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Tdm Co., Ltd.

FDA Regulatory Profile

Tdm Co., Ltd. has 0 FDA recalls, 2 inspections, 14 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Tdm Co., Ltd." and its spelling variants "Tdm Co", "Tdm".

Latest inspection: Dec 11, 2024 · NAI
Latest 510(k): Oct 15, 2026

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	14	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA Inspections

2 inspections from Aug 22, 2024 to Dec 11, 2024.

Date	Site	Product	Classification	FEI
Dec 11, 2024	Gwangju, Korea (The Republic Of)	Devices	No Action Indicated (NAI)	3014257776
Aug 22, 2024	La Crosse, WI	Food/Cosmetics	No Action Indicated (NAI)	3005314668

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-Inspected Facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3014257776	Gwangju, Korea (The Republic Of)	1	Dec 11, 2024
FEI 3005314668	La Crosse, WI	1	Aug 22, 2024

Recent 510(k) Clearances

14 510(k) clearances from Mar 15, 2018 to Oct 15, 2026.

K-Number	Device	Date
K263269	Park's Pectus System	Oct 15, 2026
K261611	TDM Large Bone Plate and Screw System	Oct 2, 2026
K263062	NOVIX Pedicle Screw System	Oct 1, 2026
K241128	TDM Plate and Screw System	Dec 5, 2024
K230071	Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus…	Aug 22, 2024
K240423	TDM Anterior Cervical Plate System	Apr 8, 2024
K232115	TDM Large Bone Plate and Screw System	Apr 5, 2024
K231860	TDM Screw System	Jan 18, 2024
K221844	TDM Lumbar Interbody Fusion Cage System	Aug 17, 2022
K220285	PINE Pedicle Screw System	May 19, 2022
K191057	Park's Pectus System	Mar 19, 2020
K190391	TDM Plate and Screw Systems	Nov 15, 2019
K190830	TDM Screw Systems	Sep 13, 2019
K171808	TDM Plate and Screw System	Mar 15, 2018

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