NuVasive LessRay with Enhanced Tracking

Q: What is the product code of K170800?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.

FDA 510(k) K170800 · Nu Vasive, Incorporated

Substantially Equivalent

510(k) numberK170800

Submission

Device name: NuVasive LessRay with Enhanced Tracking
Applicant: Nu Vasive, Incorporated
San Diego, CA, US
Received: March 17, 2017
Decision date: August 18, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OWB – Interventional Fluoroscopic X-Ray System
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1650
Specialty: Radiology

Interventional fluoroscopy

Other 510(k)s with product code OWB

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K261413	Extron 3;EXTRON 6OWB · Traditional	DRTECH Corporation	08/19/2026SE
K254205	Zenition 30OWB · Traditional	Philips Medical Systems Nederland B.V.	08/07/2026SE
K260607	Shield System (Siemens 30x40)OWB · Special	Radiaction , Ltd.	07/31/2026SE
K253670	SmartCT (R3.0 (L10))OWB · Abbreviated	Philips Medical Systems B.V.	07/10/2026SE
K252735	C-beamOWB · Traditional	Pulmera, Inc.	05/22/2026SE
K252503	Intelligent NROWB · Traditional	Canon, Inc.	04/30/2026SE
K254173	ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional	Siemens Medical Solutions USA, Inc.	04/24/2026SE
K253752	ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional	Siemens Medical Solutions USA, Inc.	04/23/2026SE
K252229	Belliger AceOWB · Traditional	Genoray Co., Ltd.	04/02/2026SE

More from Genoray Co., Ltd.

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K230989	Rod Registration FrameOLO · Special	05/05/2023SE
K223181	NuVasive Reline SystemNKB · Traditional	01/11/2023SE
K221751	NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceOVD · Traditional	10/21/2022SE
K221388	NuVasive Reline Cervical SystemNKG · Traditional	09/09/2022SE
K220478	NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemMAX · Traditional	06/21/2022SE
K213654	NuVasive Reline Cervical SystemNKG · Traditional	02/23/2022SE
K203714	NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…MAX · Traditional	12/23/2021SE
K212446	NuVasive Anterior Cervical Plate SystemsKWQ · Traditional	11/03/2021SE

Questions and answers

When was NuVasive LessRay with Enhanced Tracking cleared by the FDA?

NuVasive LessRay with Enhanced Tracking (K170800) received a 510(k) decision of Substantially Equivalent on August 18, 2017, 154 days after the submission was received.

What is the product code of K170800?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.