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FDA 510(k)

EBI ACUMEN SURGICAL NAVIGATION SYSTEM

K-Number: K031732 · 2003-10-15

ApplicantEbi, L.P.
Decision Date2003-10-15
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EBI ACUMEN SURGICAL NAVIGATION 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 2003-10-15 under 510(k) number K031732. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBI ACUMEN SURGICAL NAVIGATION SYSTEM?

EBI ACUMEN SURGICAL NAVIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-15. The listed applicant is Ebi, L.P.. The 510(k) number is K031732.

When did EBI ACUMEN SURGICAL NAVIGATION SYSTEM receive FDA 510(k) clearance?

EBI ACUMEN SURGICAL NAVIGATION SYSTEM received FDA 510(k) clearance on 2003-10-15, under 510(k) number K031732.

Who is the listed applicant for EBI ACUMEN SURGICAL NAVIGATION 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 ACUMEN SURGICAL NAVIGATION SYSTEM?

The FDA product code for EBI ACUMEN SURGICAL NAVIGATION SYSTEM is HAW.

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Other records listing Ebi, L.P. as applicant

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Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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