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FDA 510(k)

EBI 5.5 HELICAL FLANGE SPINAL SYSTEM

K-Number: K061441 · 2006-07-25

ApplicantEbi, L.P.
Decision Date2006-07-25
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBI 5.5 HELICAL FLANGE 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 2006-07-25 under 510(k) number K061441. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBI 5.5 HELICAL FLANGE SPINAL SYSTEM?

EBI 5.5 HELICAL FLANGE SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-25. The listed applicant is Ebi, L.P.. The 510(k) number is K061441.

When did EBI 5.5 HELICAL FLANGE SPINAL SYSTEM receive FDA 510(k) clearance?

EBI 5.5 HELICAL FLANGE SPINAL SYSTEM received FDA 510(k) clearance on 2006-07-25, under 510(k) number K061441.

Who is the listed applicant for EBI 5.5 HELICAL FLANGE 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 EBI 5.5 HELICAL FLANGE SPINAL SYSTEM?

The FDA product code for EBI 5.5 HELICAL FLANGE SPINAL SYSTEM is MNH. This falls under the ENT category.

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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: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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