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FDA 510(k)

SHIRAZ POSTERIOR SYSTEM

K-Number: K033947 · 2004-03-04

ApplicantSpine Next America
Decision Date2004-03-04
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SHIRAZ POSTERIOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine Next America. It received FDA 510(k) clearance on 2004-03-04 under 510(k) number K033947. 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 SHIRAZ POSTERIOR SYSTEM?

SHIRAZ POSTERIOR SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-04. The listed applicant is Spine Next America. The 510(k) number is K033947.

When did SHIRAZ POSTERIOR SYSTEM receive FDA 510(k) clearance?

SHIRAZ POSTERIOR SYSTEM received FDA 510(k) clearance on 2004-03-04, under 510(k) number K033947.

Who is the listed applicant for SHIRAZ POSTERIOR SYSTEM?

The FDA 510(k) record lists Spine Next America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHIRAZ POSTERIOR SYSTEM?

The FDA product code for SHIRAZ POSTERIOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Spine Next America 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.

K033965SHIRAZ-ANTERIOR SYSTEMK033772SHIRAZ-JAVA SPINAL FIXATION 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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