C-Ps PEEK Optima Cervical Interbody Spacer, L-Ps PEEK Optima Lumbar Interbody Spacer

Q: What is the product code of K092540?

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) K092540 · Rsb Spine, LLC

Substantially Equivalent

510(k) numberK092540

Submission

Device name: C-Ps PEEK Optima Cervical Interbody Spacer, L-Ps PEEK Optima Lumbar Interbody Spacer
Applicant: Rsb Spine, LLC
Chesterland, OH, US
Received: August 19, 2009
Decision date: January 27, 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
K092070	Interplate CKWQ · Traditional	10/06/2009SE
K081194	Interplate PEEK Cervical Interbody Fusion Device (Ifd)OVE · Special	05/29/2008SE
K071922	Interplate Interbody Fusion Device, Models C, CGC, L and LGCOVD · Traditional	09/18/2007SE
K071372	Modification to: Interplate VBR SystemMQP · Special	06/11/2007SE
K070316	Interplate VBR SystemMQP · Traditional	04/19/2007SE
K061401	Interplate VBR SystemMQP · Traditional	08/18/2006SE

Questions and answers

When was C-Ps PEEK Optima Cervical Interbody Spacer, L-Ps PEEK Optima Lumbar Interbody Spacer cleared by the FDA?

C-Ps PEEK Optima Cervical Interbody Spacer, L-Ps PEEK Optima Lumbar Interbody Spacer (K092540) received a 510(k) decision of Substantially Equivalent on January 27, 2010, 161 days after the submission was received.

What is the product code of K092540?

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.