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FDA 510(k)

SHIRAZ-ANTERIOR SYSTEM

K-Number: K033965 · 2004-03-04

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

Device Summary

SHIRAZ-ANTERIOR 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 K033965. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIRAZ-ANTERIOR SYSTEM?

SHIRAZ-ANTERIOR 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 K033965.

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

SHIRAZ-ANTERIOR SYSTEM received FDA 510(k) clearance on 2004-03-04, under 510(k) number K033965.

Who is the listed applicant for SHIRAZ-ANTERIOR 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-ANTERIOR SYSTEM?

The FDA product code for SHIRAZ-ANTERIOR SYSTEM is KWQ.

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 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.

K033947SHIRAZ POSTERIOR SYSTEMK033772SHIRAZ-JAVA SPINAL FIXATION SYSTEM

Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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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