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FDA 510(k)

CORE PEDICLE SCREW SYSTEM

K-Number: K131522 · 2013-08-09

ApplicantCore-Nexus
Decision Date2013-08-09
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORE PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Core-Nexus. It received FDA 510(k) clearance on 2013-08-09 under 510(k) number K131522. 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 CORE PEDICLE SCREW SYSTEM?

CORE PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-09. The listed applicant is Core-Nexus. The 510(k) number is K131522.

When did CORE PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

CORE PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2013-08-09, under 510(k) number K131522.

Who is the listed applicant for CORE PEDICLE SCREW SYSTEM?

The FDA 510(k) record lists Core-Nexus as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORE PEDICLE SCREW SYSTEM?

The FDA product code for CORE PEDICLE SCREW 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 Core-Nexus 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.

K131520NEXUS ANTERIOR CERVICAL PLATE 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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