CONDUIT Instruments

Q: What is the product code of K210728?

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) K210728 · Medos International SARL

Substantially Equivalent

510(k) numberK210728

Submission

Device name: CONDUIT Instruments
Applicant: Medos International SARL
Lelocle, CH
Received: March 11, 2021
Decision date: May 6, 2021
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

More from Life Spine, Inc.

510(k)	Device	Decision
K254157	CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyOLO · Traditional	05/26/2026SE
K260240	SYMPHONY Navigation Ready InstrumentsOLO · Traditional	03/27/2026SE
K253249	TriALTIS Spine SystemNKB · Special	10/21/2025SE
K243249	TriALTIS Spine SystemNKB · Traditional	01/17/2025SE
K241893	CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysOLO · Traditional	09/16/2024SE
K242042	TriALTIS Spine SystemNKB · Traditional	09/09/2024SE
K233684	TriALTIS Spine SystemNKB · Special	12/12/2023SE
K233366	SYMPHONY OCT SystemNKG · Special	11/09/2023SE
K232492	2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite…MBI · Traditional	10/06/2023SE
K231479	TriALTIS Spine SystemNKB · Traditional	09/22/2023SE

Questions and answers

When was CONDUIT Instruments cleared by the FDA?

CONDUIT Instruments (K210728) received a 510(k) decision of Substantially Equivalent on May 6, 2021, 56 days after the submission was received.

What is the product code of K210728?

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.