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FDA 510(k)

OUTOLOGOUS SPINAL FIXATION SYSTEM

K-Number: K040493 · 2004-09-03

ApplicantOrthopedic Sciences, Inc.
Decision Date2004-09-03
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OUTOLOGOUS SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Sciences, Inc.. It received FDA 510(k) clearance on 2004-09-03 under 510(k) number K040493. 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 OUTOLOGOUS SPINAL FIXATION SYSTEM?

OUTOLOGOUS SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-03. The listed applicant is Orthopedic Sciences, Inc.. The 510(k) number is K040493.

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

OUTOLOGOUS SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2004-09-03, under 510(k) number K040493.

Who is the listed applicant for OUTOLOGOUS SPINAL FIXATION SYSTEM?

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

What is the FDA product code for OUTOLOGOUS SPINAL FIXATION SYSTEM?

The FDA product code for OUTOLOGOUS SPINAL FIXATION SYSTEM is MNI.

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Other records listing Orthopedic Sciences, Inc. as applicant

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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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