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FDA 510(k)

AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM

K-Number: K061248 · 2006-08-31

ApplicantMedtronic Navigation, Inc.
Decision Date2006-08-31
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2006-08-31 under 510(k) number K061248. 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 AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM?

AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-31. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K061248.

When did AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM receive FDA 510(k) clearance?

AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM received FDA 510(k) clearance on 2006-08-31, under 510(k) number K061248.

Who is the listed applicant for AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM?

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

What is the FDA product code for AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM?

The FDA product code for AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM is HAW.

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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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