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FDA 510(k)

DANEK SACRAL HOOK

K-Number: K901590 · 1990-08-21

ApplicantDanek Medical, Inc.
Decision Date1990-08-21
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DANEK SACRAL HOOK 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 1990-08-21 under 510(k) number K901590. 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 DANEK SACRAL HOOK?

DANEK SACRAL HOOK is a medical device that received FDA 510(k) clearance on 1990-08-21. The listed applicant is Danek Medical, Inc.. The 510(k) number is K901590.

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

DANEK SACRAL HOOK received FDA 510(k) clearance on 1990-08-21, under 510(k) number K901590.

Who is the listed applicant for DANEK SACRAL HOOK?

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?

The FDA product code for DANEK SACRAL HOOK 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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

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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