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FDA 510(k)

HEMI-ARC SURGICAL NAVIGATOR

K-Number: K013257 · 2001-10-30

ApplicantNuvasive, Inc.
Decision Date2001-10-30
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HEMI-ARC SURGICAL NAVIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 2001-10-30 under 510(k) number K013257. 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 HEMI-ARC SURGICAL NAVIGATOR?

HEMI-ARC SURGICAL NAVIGATOR is a medical device that received FDA 510(k) clearance on 2001-10-30. The listed applicant is Nuvasive, Inc.. The 510(k) number is K013257.

When did HEMI-ARC SURGICAL NAVIGATOR receive FDA 510(k) clearance?

HEMI-ARC SURGICAL NAVIGATOR received FDA 510(k) clearance on 2001-10-30, under 510(k) number K013257.

Who is the listed applicant for HEMI-ARC SURGICAL NAVIGATOR?

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

What is the FDA product code for HEMI-ARC SURGICAL NAVIGATOR?

The FDA product code for HEMI-ARC SURGICAL NAVIGATOR is HAW.

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Other records listing Nuvasive, Inc. 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.

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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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