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FDA 510(k)

HAV-LOK BUNION CORRECTION SYSTEM

K-Number: K082384 · 2008-12-08

ApplicantInstratek, Inc.
Decision Date2008-12-08
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HAV-LOK BUNION CORRECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Instratek, Inc.. It received FDA 510(k) clearance on 2008-12-08 under 510(k) number K082384. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAV-LOK BUNION CORRECTION SYSTEM?

HAV-LOK BUNION CORRECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-08. The listed applicant is Instratek, Inc.. The 510(k) number is K082384.

When did HAV-LOK BUNION CORRECTION SYSTEM receive FDA 510(k) clearance?

HAV-LOK BUNION CORRECTION SYSTEM received FDA 510(k) clearance on 2008-12-08, under 510(k) number K082384.

Who is the listed applicant for HAV-LOK BUNION CORRECTION SYSTEM?

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

What is the FDA product code for HAV-LOK BUNION CORRECTION SYSTEM?

The FDA product code for HAV-LOK BUNION CORRECTION SYSTEM is HTN.

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Other records listing Instratek, Inc. as applicant

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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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