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FDA 510(k)

CONVERGENCE CERVICAL SPINAL SYSTEM

K-Number: K010639 · 2001-05-30

ApplicantSpinal Innovations, LLC
Decision Date2001-05-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONVERGENCE CERVICAL SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Innovations, LLC. It received FDA 510(k) clearance on 2001-05-30 under 510(k) number K010639. 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 CONVERGENCE CERVICAL SPINAL SYSTEM?

CONVERGENCE CERVICAL SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2001-05-30. The listed applicant is Spinal Innovations, LLC. The 510(k) number is K010639.

When did CONVERGENCE CERVICAL SPINAL SYSTEM receive FDA 510(k) clearance?

CONVERGENCE CERVICAL SPINAL SYSTEM received FDA 510(k) clearance on 2001-05-30, under 510(k) number K010639.

Who is the listed applicant for CONVERGENCE CERVICAL SPINAL SYSTEM?

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

What is the FDA product code for CONVERGENCE CERVICAL SPINAL SYSTEM?

The FDA product code for CONVERGENCE CERVICAL SPINAL 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 Spinal Innovations, 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.

K022997SPECTRUM CERVICAL SPINAL SYSTEMK013196ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEMK002069ASCEND 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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