Camber Spine Coveris Cervical Cage

Q: What is the product code of K133529?

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) K133529 · Camber Spine

Substantially Equivalent

510(k) numberK133529

Submission

Device name: Camber Spine Coveris Cervical Cage
Applicant: Camber Spine
Newtown Square, PA, US
Received: November 15, 2013
Decision date: March 20, 2014
Decision: Substantially Equivalent (SESE)
Type: Traditional 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
K143490	VERTA Corpectomy CageMQP · Traditional	01/26/2015SE
K133366	Orthros Posterior Stabilization SystemNKB · Traditional	04/08/2014SE
K134038	Camber Spine Diagon Oblique CageMAX · Special	03/20/2014SE

Questions and answers

When was Camber Spine Coveris Cervical Cage cleared by the FDA?

Camber Spine Coveris Cervical Cage (K133529) received a 510(k) decision of Substantially Equivalent on March 20, 2014, 125 days after the submission was received.

What is the product code of K133529?

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.