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FDA 510(k)

EMINENT SPINE INTERBODY FUSION SYSTEM

K-Number: K090064 · 2009-04-09

ApplicantEminent Spine
Decision Date2009-04-09
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMINENT SPINE INTERBODY FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eminent Spine. It received FDA 510(k) clearance on 2009-04-09 under 510(k) number K090064. 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 EMINENT SPINE INTERBODY FUSION SYSTEM?

EMINENT SPINE INTERBODY FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-09. The listed applicant is Eminent Spine. The 510(k) number is K090064.

When did EMINENT SPINE INTERBODY FUSION SYSTEM receive FDA 510(k) clearance?

EMINENT SPINE INTERBODY FUSION SYSTEM received FDA 510(k) clearance on 2009-04-09, under 510(k) number K090064.

Who is the listed applicant for EMINENT SPINE INTERBODY FUSION SYSTEM?

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

What is the FDA product code for EMINENT SPINE INTERBODY FUSION SYSTEM?

The FDA product code for EMINENT SPINE INTERBODY FUSION SYSTEM is MAX.

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Other records listing Eminent Spine 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.

K250894Eminent Spine Posterior SI SystemK241663Eminent Spine 3D Titanium Pedicle Screw SystemK242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemK212701Eminent Spine 3D Cervical Interbody Fusion SystemK221936Standalone ALIF Interbody Fusion SystemK103068KING COBRA ANTERIOR CERVICAL PLATE

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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.

K261049SCALA® TLSpineart SAK261430TruLift 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.

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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