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FDA 510(k)

ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01

K-Number: K080024 · 2008-01-24

ApplicantK2m, Inc.
Decision Date2008-01-24
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2008-01-24 under 510(k) number K080024. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01?

ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 is a medical device that received FDA 510(k) clearance on 2008-01-24. The listed applicant is K2m, Inc.. The 510(k) number is K080024.

When did ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 receive FDA 510(k) clearance?

ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 received FDA 510(k) clearance on 2008-01-24, under 510(k) number K080024.

Who is the listed applicant for ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01?

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 SPACER, MODEL K2-07-1004-01, K2-07-1005-01?

The FDA product code for ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 is MQP.

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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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