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FDA 510(k)

EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE

K-Number: K050675 · 2005-04-11

ApplicantDepuy Spine, Inc.
Decision Date2005-04-11
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2005-04-11 under 510(k) number K050675. 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 EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE?

EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE is a medical device that received FDA 510(k) clearance on 2005-04-11. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K050675.

When did EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE receive FDA 510(k) clearance?

EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE received FDA 510(k) clearance on 2005-04-11, under 510(k) number K050675.

Who is the listed applicant for EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE?

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

What is the FDA product code for EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE?

The FDA product code for EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE is MNI.

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Other records listing Depuy Spine, 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.

K201831CONFIDENCE Spinal Cement SystemK111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMK121020VIPER SYSTEMK110353MOUNTAINEER OCT SPINAL SYSTEMK110216EXPEDIUM SYSTEM, VIPER SYSTEMK103133VEPER SYSTEM, EXPEDIUM SYSTEM

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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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