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FDA 510(k)

Elite Expandable Interbody Fusion Device

K-Number: K162879 · 2017-01-30

ApplicantSpineology, Inc.
Decision Date2017-01-30
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Elite Expandable Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2017-01-30 under 510(k) number K162879. 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 Elite Expandable Interbody Fusion Device?

Elite Expandable Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2017-01-30. The listed applicant is Spineology, Inc.. The 510(k) number is K162879.

When did Elite Expandable Interbody Fusion Device receive FDA 510(k) clearance?

Elite Expandable Interbody Fusion Device received FDA 510(k) clearance on 2017-01-30, under 510(k) number K162879.

Who is the listed applicant for Elite Expandable Interbody Fusion Device?

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

What is the FDA product code for Elite Expandable Interbody Fusion Device?

The FDA product code for Elite Expandable Interbody Fusion Device is MAX.

Other records listing Spineology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemK251943Spineology Navigation InstrumentsK230927OptiMesh Multiplanar Expandable Interbody Fusion SystemK231781OptiMesh Multiplanar Expandable Interbody Fusion SystemK213876Spineology Navigation InstrumentsK210155Duo Expandable Interbody Fusion System

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Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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.

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