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FDA 510(k)

T-BOLT AND NUT

K-Number: K911306 · 1991-09-10

ApplicantDanek Medical, Inc.
Decision Date1991-09-10
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T-BOLT AND NUT is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1991-09-10 under 510(k) number K911306. 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 T-BOLT AND NUT?

T-BOLT AND NUT is a medical device that received FDA 510(k) clearance on 1991-09-10. The listed applicant is Danek Medical, Inc.. The 510(k) number is K911306.

When did T-BOLT AND NUT receive FDA 510(k) clearance?

T-BOLT AND NUT received FDA 510(k) clearance on 1991-09-10, under 510(k) number K911306.

Who is the listed applicant for T-BOLT AND NUT?

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

What is the FDA product code for T-BOLT AND NUT?

The FDA product code for T-BOLT AND NUT is HTN.

Other records listing Danek Medical, 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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