Vista-S Device, Associated Instrumentation

Q: What is the product code of K133784?

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) K133784 · Zimmer Trabecular Metal Technology

Substantially Equivalent

510(k) numberK133784

Submission

Device name: Vista-S Device, Associated Instrumentation
Applicant: Zimmer Trabecular Metal Technology
Parsippany, NJ, US
Received: December 12, 2013
Decision date: July 7, 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
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K120203	TM-400 DeviceMAX · Traditional	06/15/2012SE
K113561	TM Ardis Interbody System TM Ardis Interbody System InstrumenationMAX · Traditional	05/29/2012SE
K111983	Vista-S Device Model 08/06-401-XXXXX, 08/06-402-XXXXXXODP · Traditional	11/18/2011SE
K103517	Trabecular Metal Femoral Cone AugmentsMBH · Traditional	02/15/2011SE
K103033	Trabecular Metal Fusion Device Model 06-101-XXXXX, 06-102-XXXXX and 08-100-XXXXXODP · Traditional	01/10/2011SE
K102896	Trabecular Metal Tibial Cone AugmentsMBH · Traditional	12/13/2010SE
K093127	Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument SetMQP · Traditional	03/04/2010SE
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Questions and answers

When was Vista-S Device, Associated Instrumentation cleared by the FDA?

Vista-S Device, Associated Instrumentation (K133784) received a 510(k) decision of Substantially Equivalent on July 7, 2014, 207 days after the submission was received.

What is the product code of K133784?

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.