Impix Manta Cervical Interbody Device

Q: What is the product code of K100484?

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

FDA 510(k) K100484 · Medicrea

Substantially Equivalent

510(k) numberK100484

Submission

Device name: Impix Manta Cervical Interbody Device
Applicant: Medicrea
Round Rock, TX, US
Received: February 18, 2010
Decision date: March 16, 2010
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

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

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

Other 510(k)s with product code ODP

510(k)	Device	Applicant	Decision
K262595	VariLift-C Cervical Interbody Fusion SystemODP · Special	Wenzel Spine, Inc.	08/26/2026SE
K262489	BluEX Cervical Expandable Cage SystemODP · Special	L&K BIOMED Co., Ltd.	08/18/2026SE
K253041	3d Cage CervicalODP · Traditional	Fims Co., Ltd.	07/23/2026SE
K262061	Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special	Stryker Spine	07/17/2026SE
K254130	C.A. Medical Interbody Fusion SystemODP · Special	C.A. Medical, LLC	07/08/2026SE
K260840	BluEX Cervical Expandable Cage SystemODP · Traditional	L&K BIOMED Co., Ltd.	05/16/2026SE
K260850	Osteomni Spinal Cages SystemODP · Traditional	Osteomni, Inc.	05/12/2026SE
K260549	ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special	Zsfab, Inc.	04/24/2026SE
K253260	ORIO-3D Cage SystemODP · Traditional	SpineCraft	04/16/2026SE
K260340	HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional	HC Biologics, LLC	04/13/2026SE

More from HC Biologics, LLC

510(k)	Device	Decision
K062136	Pass 2 Spinal SystemMNI · Traditional	10/06/2006SE
K050490	Osmosys Calcium Phosphate Ceramic Bone FillerMQV · Traditional	04/11/2005SE
K032094	Passmed Spinal SystemKWP · Traditional	11/14/2003SE

Questions and answers

When was Impix Manta Cervical Interbody Device cleared by the FDA?

Impix Manta Cervical Interbody Device (K100484) received a 510(k) decision of Substantially Equivalent on March 16, 2010, 26 days after the submission was received.

What is the product code of K100484?

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