Range Spinal System

Q: What is the product code of K131784?

The FDA product code is OSH – Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis, a Class II (moderate risk) device regulated under 21 CFR 888.3070.

FDA 510(k) K131784 · K2m, Inc.

Substantially Equivalent

510(k) numberK131784

Submission

Device name: Range Spinal System
Applicant: K2m, Inc.
Leesburg, VA, US
Received: June 18, 2013
Decision date: August 30, 2013
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OSH – Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3070
Specialty: Orthopedic
Implant: Yes

Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.

Other 510(k)s with product code OSH

510(k)	Device	Applicant	Decision
K153446	OLYMPIC Posterior Spinal Fixation SystemOSH · Traditional	Astura Medical	04/08/2016SE
K140276	CD Horizon Spinal SystemOSH · Traditional	Medtronic Sofamor Danek	03/13/2014SE
K132574	Pass LP Spinal SystemOSH · Traditional	Medicrea International	11/08/2013SE
K132303	Implanet Spine SystemOSH · Traditional	Implanet, S.A.	10/10/2013SE
K132575	Pass LP Spinal SystemOSH · Special	Medicrea International	10/03/2013SE
K131802	Expedium, Viper. Viper 2 Spine SystemOSH · Special	Depuy Spine, A Johnson & Johnson Company	09/12/2013SE
K131615	Polaris Spinal SystemOSH · Traditional	Biomet Spine (Aka Ebi, LLC)	09/04/2013SE
K131321	CD Horizon Spinal SystemOSH · Special	Medtronic Sofamor Danek USA	06/05/2013SE
K124058	Creo Stabilization SystemOSH · Traditional	Globus Medical, Inc.	05/13/2013SE
K131030	Range Spinal SystemOSH · Special	K2m, Inc.	05/09/2013SE

More from K2m, Inc.

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K252873	Q Interbody InstrumentsOLO · Traditional	02/06/2026SE
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K202528	Cannulated Power Driver AttachmentNKB · Traditional	10/26/2020SE
K201006	K2M Navigation InstrumentsOLO · Special	08/07/2020SE
K193203	MOJAVE Expandable Interbody SystemMAX · Special	02/18/2020SE
K193129	Yukon OCT Spinal SystemNKG · Traditional	02/07/2020SE
K192911	Brainlab Compatible K2M Navigation InstrumentsOLO · Special	11/14/2019SE
K190179	SAHARA Stabilization SystemOVD · Traditional	10/03/2019SE

Questions and answers

When was Range Spinal System cleared by the FDA?

Range Spinal System (K131784) received a 510(k) decision of Substantially Equivalent on August 30, 2013, 73 days after the submission was received.

What is the product code of K131784?

The FDA product code is OSH – Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis, a Class II (moderate risk) device regulated under 21 CFR 888.3070.