Medical Device Manufacturer · KR , Gwangju

Tdm Co., Ltd. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2018

Recent clearances: TDM Large Bone Plate and Screw System, NOVIX Pedicle Screw System, TDM Plate and Screw System

13
Total
13
Cleared
0
Denied

FDA 510(k) Regulatory Record - Tdm Co., Ltd. Orthopedic ✕

13 devices
1-12 of 13
Cleared Oct 02, 2026
TDM Large Bone Plate and Screw System
K261611 · HRS
Orthopedic · 140d
Cleared Oct 01, 2026
NOVIX Pedicle Screw System
K263062 · NKB
Orthopedic · 30d
Cleared Dec 05, 2024
TDM Plate and Screw System
K241128 · HRS
Orthopedic · 225d
Cleared Aug 22, 2024
Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking...
K230071 · HSB
Orthopedic · 590d
Cleared Apr 08, 2024
TDM Anterior Cervical Plate System
K240423 · KWQ
Orthopedic · 55d
Cleared Apr 05, 2024
TDM Large Bone Plate and Screw System
K232115 · HRS
Orthopedic · 266d
Cleared Jan 18, 2024
TDM Screw System
K231860 · HWC
Orthopedic · 209d
Cleared Aug 17, 2022
TDM Lumbar Interbody Fusion Cage System
K221844 · MAX
Orthopedic · 54d
Cleared May 19, 2022
PINE Pedicle Screw System
K220285 · NKB
Orthopedic · 107d
Cleared Mar 19, 2020
Park's Pectus System
K191057 · HRS
Orthopedic · 332d
Cleared Nov 15, 2019
TDM Plate and Screw Systems
K190391 · HRS
Orthopedic · 269d
Cleared Sep 13, 2019
TDM Screw Systems
K190830 · HWC
Orthopedic · 165d
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