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FDA 510(k)

SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS

K-Number: K112611 · 2012-04-25

ApplicantSintea Plastek, LLC
Decision Date2012-04-25
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Sintea Plastek, LLC. It received FDA 510(k) clearance on 2012-04-25 under 510(k) number K112611. 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 SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS?

SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS is a medical device that received FDA 510(k) clearance on 2012-04-25. The listed applicant is Sintea Plastek, LLC. The 510(k) number is K112611.

When did SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS receive FDA 510(k) clearance?

SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS received FDA 510(k) clearance on 2012-04-25, under 510(k) number K112611.

Who is the listed applicant for SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS?

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

What is the FDA product code for SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS?

The FDA product code for SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS is MNI.

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Other records listing Sintea Plastek, 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.

K101886DSC/ALF SPINAL 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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