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FDA 510(k)

DIAMOND ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K100265 · 2010-05-13

ApplicantAmendia, Inc.
Decision Date2010-05-13
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DIAMOND ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amendia, Inc.. It received FDA 510(k) clearance on 2010-05-13 under 510(k) number K100265. 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 DIAMOND ANTERIOR CERVICAL PLATE SYSTEM?

DIAMOND ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-13. The listed applicant is Amendia, Inc.. The 510(k) number is K100265.

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

DIAMOND ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2010-05-13, under 510(k) number K100265.

Who is the listed applicant for DIAMOND ANTERIOR CERVICAL PLATE SYSTEM?

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

What is the FDA product code for DIAMOND ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for DIAMOND ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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Other records listing Amendia, Inc. 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.

K160924Amendia Interbody Fusion DevicesK161842Overwatch Spine SystemK152920Savannah-T® Pedicle Screw SystemK153152Syzygy Stabilization SystemK160291Optimus ALIF SystemK152972Amendia Stand-Alone Cervical System

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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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