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FDA 510(k)

ALTUM ANTERIOR CERVICAL PLATE

K-Number: K103505 · 2011-03-15

ApplicantSpinecraft, LLC
Decision Date2011-03-15
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALTUM ANTERIOR CERVICAL PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Spinecraft, LLC. It received FDA 510(k) clearance on 2011-03-15 under 510(k) number K103505. 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 ALTUM ANTERIOR CERVICAL PLATE?

ALTUM ANTERIOR CERVICAL PLATE is a medical device that received FDA 510(k) clearance on 2011-03-15. The listed applicant is Spinecraft, LLC. The 510(k) number is K103505.

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

ALTUM ANTERIOR CERVICAL PLATE received FDA 510(k) clearance on 2011-03-15, under 510(k) number K103505.

Who is the listed applicant for ALTUM ANTERIOR CERVICAL PLATE?

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

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

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

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Other records listing Spinecraft, LLC 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.

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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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