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FDA 510(k)

DELTA SPINAL FUSION SYSTEM

K-Number: K071857 · 2007-08-08

ApplicantJemo Spine, LLC
Decision Date2007-08-08
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DELTA SPINAL FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Jemo Spine, LLC. It received FDA 510(k) clearance on 2007-08-08 under 510(k) number K071857. 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 DELTA SPINAL FUSION SYSTEM?

DELTA SPINAL FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-08. The listed applicant is Jemo Spine, LLC. The 510(k) number is K071857.

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

DELTA SPINAL FUSION SYSTEM received FDA 510(k) clearance on 2007-08-08, under 510(k) number K071857.

Who is the listed applicant for DELTA SPINAL FUSION SYSTEM?

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

What is the FDA product code for DELTA SPINAL FUSION SYSTEM?

The FDA product code for DELTA SPINAL FUSION SYSTEM is MNI.

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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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