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FDA 510(k)

TSRH OFFSET AND SIDE-LOADING HOOKS

K-Number: K903461 · 1990-12-05

ApplicantDanek Medical, Inc.
Decision Date1990-12-05
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

TSRH OFFSET AND SIDE-LOADING HOOKS 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 1990-12-05 under 510(k) number K903461. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the TSRH OFFSET AND SIDE-LOADING HOOKS?

TSRH OFFSET AND SIDE-LOADING HOOKS is a medical device that received FDA 510(k) clearance on 1990-12-05. The listed applicant is Danek Medical, Inc.. The 510(k) number is K903461.

When did TSRH OFFSET AND SIDE-LOADING HOOKS receive FDA 510(k) clearance?

TSRH OFFSET AND SIDE-LOADING HOOKS received FDA 510(k) clearance on 1990-12-05, under 510(k) number K903461.

Who is the listed applicant for TSRH OFFSET AND SIDE-LOADING HOOKS?

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 TSRH OFFSET AND SIDE-LOADING HOOKS?

The FDA product code for TSRH OFFSET AND SIDE-LOADING HOOKS is KWP.

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Related Devices (Code: KWP)

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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