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FDA 510(k)

DANEK SACRAL HOOK, MODIFICATION

K-Number: K911379 · 1991-09-11

ApplicantDanek Medical, Inc.
Decision Date1991-09-11
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DANEK SACRAL HOOK, MODIFICATION 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 1991-09-11 under 510(k) number K911379. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANEK SACRAL HOOK, MODIFICATION?

DANEK SACRAL HOOK, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-09-11. The listed applicant is Danek Medical, Inc.. The 510(k) number is K911379.

When did DANEK SACRAL HOOK, MODIFICATION receive FDA 510(k) clearance?

DANEK SACRAL HOOK, MODIFICATION received FDA 510(k) clearance on 1991-09-11, under 510(k) number K911379.

Who is the listed applicant for DANEK SACRAL HOOK, MODIFICATION?

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 DANEK SACRAL HOOK, MODIFICATION?

The FDA product code for DANEK SACRAL HOOK, MODIFICATION is KWP.

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Other records listing Danek Medical, Inc. as applicant

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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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