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FDA 510(k)

SCS CLARIS SPINAL SCREWS, TYPES V,G,E

K-Number: K011807 · 2001-08-07

ApplicantOrtho Tec, LLC
Decision Date2001-08-07
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCS CLARIS SPINAL SCREWS, TYPES V,G,E 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 2001-08-07 under 510(k) number K011807. 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 SCS CLARIS SPINAL SCREWS, TYPES V,G,E?

SCS CLARIS SPINAL SCREWS, TYPES V,G,E is a medical device that received FDA 510(k) clearance on 2001-08-07. The listed applicant is Ortho Tec, LLC. The 510(k) number is K011807.

When did SCS CLARIS SPINAL SCREWS, TYPES V,G,E receive FDA 510(k) clearance?

SCS CLARIS SPINAL SCREWS, TYPES V,G,E received FDA 510(k) clearance on 2001-08-07, under 510(k) number K011807.

Who is the listed applicant for SCS CLARIS SPINAL SCREWS, TYPES V,G,E?

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 SCS CLARIS SPINAL SCREWS, TYPES V,G,E?

The FDA product code for SCS CLARIS SPINAL SCREWS, TYPES V,G,E 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.

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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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