FDA 510(k)

TDM Lumbar Interbody Fusion Cage System

K-Number: K221844 · 2022-08-17

Decision Date2022-08-17

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TDM Lumbar Interbody Fusion Cage System is a medical device manufactured by Tdm Co., Ltd.. It received FDA 510(k) clearance on 2022-08-17 under approval number K221844. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDM Lumbar Interbody Fusion Cage System?

TDM Lumbar Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2022-08-17. It is manufactured by Tdm Co., Ltd.. The 510(k) number is K221844.

When was TDM Lumbar Interbody Fusion Cage System approved by the FDA?

TDM Lumbar Interbody Fusion Cage System received FDA 510(k) clearance on 2022-08-17, under approval number K221844.

What company makes TDM Lumbar Interbody Fusion Cage System?

TDM Lumbar Interbody Fusion Cage System is manufactured by Tdm Co., Ltd..

What is the FDA product code for TDM Lumbar Interbody Fusion Cage System?

The FDA product code for TDM Lumbar Interbody Fusion Cage System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Tdm Co., Ltd.

K171808TDM Plate and Screw System K190391TDM Plate and Screw Systems K190830TDM Screw Systems K191057Park's Pectus System K220285PINE Pedicle Screw System K241128TDM Plate and Screw System

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.