TDM Lumbar Interbody Fusion Cage System

Q: What is the product code of K221844?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K221844 · Tdm Co., Ltd.

Substantially Equivalent

510(k) numberK221844

Submission

Device name: TDM Lumbar Interbody Fusion Cage System
Applicant: Tdm Co., Ltd.
Gwangju, KR
Received: June 24, 2022
Decision date: August 17, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other 510(k)s with product code MAX

510(k)	Device	Applicant	Decision
K261049	Scala® TLMAX · Traditional	Spineart SA	08/20/2026SE
K261430	TruLift Expandable SystemMAX · Traditional	Life Spine, Inc.	07/28/2026SE
K253011	Catalyft PL Expandable Interbody SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/17/2026SE
K261020	Symmetrix L Spinal SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/14/2026SE
K253420	Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional	SeaSpine Orthopedics Corporation	07/01/2026SE
K253151	Fule Interbody Fusion Cage SystemMAX · Traditional	Beijing Fule Science & Technology Development…	06/15/2026SE
K261159	Exceed® Biplanar Expandable Interbody SystemMAX · Traditional	Spine Wave, Inc.	05/29/2026SE
K253894	BMD Titanium Spinal Fusion SystemMAX · Traditional	Global Biomedica s.r.o.	05/28/2026SE
K260506	Ventana® P/T Lumbar Interbody SystemMAX · Traditional	Spinal Elements, Inc.	05/15/2026SE
K260837	VersaLift Expandable SystemMAX · Traditional	Life Spine, Inc.	05/12/2026SE

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K232115	TDM Large Bone Plate and Screw SystemHRS · Traditional	04/05/2024SE
K231860	TDM Screw SystemHWC · Special	01/18/2024SE
K220285	PINE Pedicle Screw SystemNKB · Traditional	05/19/2022SE
K191057	Park's Pectus SystemHRS · Traditional	03/19/2020SE
K190391	TDM Plate and Screw SystemsHRS · Traditional	11/15/2019SE
K190830	TDM Screw SystemsHWC · Traditional	09/13/2019SE
K171808	TDM Plate and Screw SystemHRS · Traditional	03/15/2018SE

Questions and answers

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

TDM Lumbar Interbody Fusion Cage System (K221844) received a 510(k) decision of Substantially Equivalent on August 17, 2022, 54 days after the submission was received.

What is the product code of K221844?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.