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FDA 510(k)

ALEUTIAN IBF SYSTEM

K-Number: K082698 · 2009-04-21

ApplicantK2m, Inc.
Decision Date2009-04-21
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALEUTIAN IBF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2009-04-21 under 510(k) number K082698. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALEUTIAN IBF SYSTEM?

ALEUTIAN IBF SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-21. The listed applicant is K2m, Inc.. The 510(k) number is K082698.

When did ALEUTIAN IBF SYSTEM receive FDA 510(k) clearance?

ALEUTIAN IBF SYSTEM received FDA 510(k) clearance on 2009-04-21, under 510(k) number K082698.

Who is the listed applicant for ALEUTIAN IBF SYSTEM?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALEUTIAN IBF SYSTEM?

The FDA product code for ALEUTIAN IBF SYSTEM is MAX.

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Related Devices (Code: MAX)

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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