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FDA 510(k)

MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

K-Number: K000513 · 2000-03-07

ApplicantEbi, L.P.
Decision Date2000-03-07
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, L.P.. It received FDA 510(k) clearance on 2000-03-07 under 510(k) number K000513. 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 MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM?

MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2000-03-07. The listed applicant is Ebi, L.P.. The 510(k) number is K000513.

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

MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM received FDA 510(k) clearance on 2000-03-07, under 510(k) number K000513.

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

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

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

The FDA product code for MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM is KWQ.

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Other records listing Ebi, L.P. 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.

K100438POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEMK100220POLARIS SPINAL SYSTEMK093880PEANUT GROWTH CONTROL PLATING SYSTEMK092574ESL SPINAL SYSTEMK093057BIOMET VISION FOOTRING SYSTEMK092336C-THRU SPINAL 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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