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FDA 510(k)

ACUMEN SURGICAL NAVIGATION SYSTEM

K-Number: K031337 · 2003-09-15

ApplicantBiomet, Inc.
Decision Date2003-09-15
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACUMEN SURGICAL NAVIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2003-09-15 under 510(k) number K031337. 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 ACUMEN SURGICAL NAVIGATION SYSTEM?

ACUMEN SURGICAL NAVIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-15. The listed applicant is Biomet, Inc.. The 510(k) number is K031337.

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

ACUMEN SURGICAL NAVIGATION SYSTEM received FDA 510(k) clearance on 2003-09-15, under 510(k) number K031337.

Who is the listed applicant for ACUMEN SURGICAL NAVIGATION SYSTEM?

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

What is the FDA product code for ACUMEN SURGICAL NAVIGATION SYSTEM?

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

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Related Devices (Code: HAW)

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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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