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FDA 510(k)

IRIS ANTERIOR CERVICAL PLATE

K-Number: K130202 · 2013-04-29

ApplicantLife Spine, Inc.
Decision Date2013-04-29
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IRIS ANTERIOR CERVICAL PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2013-04-29 under 510(k) number K130202. 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 IRIS ANTERIOR CERVICAL PLATE?

IRIS ANTERIOR CERVICAL PLATE is a medical device that received FDA 510(k) clearance on 2013-04-29. The listed applicant is Life Spine, Inc.. The 510(k) number is K130202.

When did IRIS ANTERIOR CERVICAL PLATE receive FDA 510(k) clearance?

IRIS ANTERIOR CERVICAL PLATE received FDA 510(k) clearance on 2013-04-29, under 510(k) number K130202.

Who is the listed applicant for IRIS ANTERIOR CERVICAL PLATE?

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

What is the FDA product code for IRIS ANTERIOR CERVICAL PLATE?

The FDA product code for IRIS ANTERIOR CERVICAL PLATE is KWQ.

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Other records listing Life Spine, 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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