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FDA 510(k)

INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX

K-Number: K073232 · 2008-02-20

ApplicantSpinefrontier, Inc.
Decision Date2008-02-20
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX is the device name listed in this FDA 510(k) record. The listed applicant is Spinefrontier, Inc.. It received FDA 510(k) clearance on 2008-02-20 under 510(k) number K073232. 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 INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX?

INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX is a medical device that received FDA 510(k) clearance on 2008-02-20. The listed applicant is Spinefrontier, Inc.. The 510(k) number is K073232.

When did INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX receive FDA 510(k) clearance?

INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX received FDA 510(k) clearance on 2008-02-20, under 510(k) number K073232.

Who is the listed applicant for INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX?

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

What is the FDA product code for INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX?

The FDA product code for INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX is KWQ.

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Other records listing Spinefrontier, Inc. as applicant

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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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