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FDA 510(k)

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

K-Number: K973923 · 1998-01-13

ApplicantEbi Electro Biology
Decision Date1998-01-13
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ebi Electro Biology. It received FDA 510(k) clearance on 1998-01-13 under 510(k) number K973923. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM?

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-13. The listed applicant is Ebi Electro Biology. The 510(k) number is K973923.

When did EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM receive FDA 510(k) clearance?

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM received FDA 510(k) clearance on 1998-01-13, under 510(k) number K973923.

Who is the listed applicant for EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM?

The FDA 510(k) record lists Ebi Electro Biology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM?

The FDA product code for EBI SPINELINK ANTERIOR 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 Ebi Electro Biology 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.

K991721EBI OMEGA 21 SYSTEMK973683OMEGA 21 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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