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FDA 510(k)

MODIFICATION TO ORIA TOP CLIP SYSTEM

K-Number: K040346 · 2004-03-12

ApplicantOrtho Tec, LLC
Decision Date2004-03-12
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ORIA TOP CLIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Tec, LLC. It received FDA 510(k) clearance on 2004-03-12 under 510(k) number K040346. 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 MODIFICATION TO ORIA TOP CLIP SYSTEM?

MODIFICATION TO ORIA TOP CLIP SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-12. The listed applicant is Ortho Tec, LLC. The 510(k) number is K040346.

When did MODIFICATION TO ORIA TOP CLIP SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO ORIA TOP CLIP SYSTEM received FDA 510(k) clearance on 2004-03-12, under 510(k) number K040346.

Who is the listed applicant for MODIFICATION TO ORIA TOP CLIP SYSTEM?

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

What is the FDA product code for MODIFICATION TO ORIA TOP CLIP SYSTEM?

The FDA product code for MODIFICATION TO ORIA TOP CLIP SYSTEM is MNI.

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Other records listing Ortho Tec, LLC 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.

K040514EOVIA CALCIUM PHOSPHATE CERAMICK030958ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORSK031471ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01K023884MODIFICATION ORIA SPINAL SYSTEMK023378ORIA CLARISK031452ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03

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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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