FDA 510(k)

EXPANDABLE LUMBAR INTERBODY SYSTEM

K-Number: K130820 · 2013-08-08

Decision Date2013-08-08

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EXPANDABLE LUMBAR INTERBODY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2013-08-08 under 510(k) number K130820. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPANDABLE LUMBAR INTERBODY SYSTEM?

EXPANDABLE LUMBAR INTERBODY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-08. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K130820.

When did EXPANDABLE LUMBAR INTERBODY SYSTEM receive FDA 510(k) clearance?

EXPANDABLE LUMBAR INTERBODY SYSTEM received FDA 510(k) clearance on 2013-08-08, under 510(k) number K130820.

Who is the listed applicant for EXPANDABLE LUMBAR INTERBODY SYSTEM?

The FDA 510(k) record lists Nu Vasive, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPANDABLE LUMBAR INTERBODY SYSTEM?

The FDA product code for EXPANDABLE LUMBAR INTERBODY SYSTEM is MAX.

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Other records listing Nu Vasive, Incorporated as applicant

K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System K230894NuVasive Modulus ALIF System K230989Rod Registration Frame K223181NuVasive Reline System K221751NuVasive Cohere ALIF System Intervertebral Body Fusion Device K221388NuVasive Reline Cervical System

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Related Devices (Code: MAX)

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.