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FDA 510(k)

DIAMONDBACK SPINAL SYSTEM

K-Number: K100377 · 2010-04-22

ApplicantEminent Spine
Decision Date2010-04-22
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DIAMONDBACK SPINAL 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 2010-04-22 under 510(k) number K100377. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMONDBACK SPINAL SYSTEM?

DIAMONDBACK SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-22. The listed applicant is Eminent Spine. The 510(k) number is K100377.

When did DIAMONDBACK SPINAL SYSTEM receive FDA 510(k) clearance?

DIAMONDBACK SPINAL SYSTEM received FDA 510(k) clearance on 2010-04-22, under 510(k) number K100377.

Who is the listed applicant for DIAMONDBACK SPINAL 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 DIAMONDBACK SPINAL SYSTEM?

The FDA product code for DIAMONDBACK SPINAL SYSTEM is MNI.

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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: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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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