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FDA 510(k)

TIMX LOW BACK SYSTEM

K-Number: K984348 · 1999-01-20

ApplicantDepuy Motech Acromed
Decision Date1999-01-20
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TIMX LOW BACK SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Motech Acromed. It received FDA 510(k) clearance on 1999-01-20 under 510(k) number K984348. 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 TIMX LOW BACK SYSTEM?

TIMX LOW BACK SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-20. The listed applicant is Depuy Motech Acromed. The 510(k) number is K984348.

When did TIMX LOW BACK SYSTEM receive FDA 510(k) clearance?

TIMX LOW BACK SYSTEM received FDA 510(k) clearance on 1999-01-20, under 510(k) number K984348.

Who is the listed applicant for TIMX LOW BACK SYSTEM?

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

What is the FDA product code for TIMX LOW BACK SYSTEM?

The FDA product code for TIMX LOW BACK SYSTEM is MNI.

Related Clinical Trials

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.

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Other records listing Depuy Motech Acromed 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.

K990148STACKABLE CAGE SYSTEMK984350VSP SYSTEMK982443DOC VENTRAL CERVICAL STABILIZATION SYSTEM

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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